May 7, 2025Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Softw
Hazard: The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
May 7, 2025Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Softwa
Hazard: The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
May 7, 2025Medical DevicesFDA
Leica Biosystems Melbourne Pty Ltd recalls HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Ra
Hazard: There is a leakage issue associated with the tubing in the manifold of the instrument.
May 7, 2025Medical DevicesFDA
Belmont Instrument LLC recalls 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Rese
Hazard: Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.
May 7, 2025Medical DevicesFDA
Belmont Instrument LLC recalls Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with
Hazard: Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
May 7, 2025Medical DevicesFDA
Belmont Instrument LLC recalls Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with th
Hazard: Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
May 7, 2025Medical DevicesFDA
Belmont Instrument LLC recalls Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperth
Hazard: Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.
May 7, 2025Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Hazard: Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPaks shelf life when using the Stratus CS cTnI Acute Care Testpak.
May 7, 2025Medical DevicesFDA
Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065
Hazard: The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.
May 7, 2025Medical DevicesFDA
Trimble Ab recalls The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking precision, effici
Hazard: An issue has been identified in the production of the RTS873 robotic total stations that may result in the green aiming laser output power being above its laser safety Class 2 classification.
May 7, 2025Medical DevicesFDA
GE Medical Systems China Co., Ltd. recalls GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.
Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
May 7, 2025Medical DevicesFDA
GE Medical Systems China Co., Ltd. recalls GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.
Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
May 7, 2025Medical DevicesFDA
GE Medical Systems China Co., Ltd. recalls GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.
Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
May 7, 2025Medical DevicesFDA
GE Medical Systems China Co., Ltd. recalls GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.
Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
May 7, 2025Medical DevicesFDA
GE Medical Systems China Co., Ltd. recalls GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.
Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
May 7, 2025Medical DevicesFDA
GE Medical Systems China Co., Ltd. recalls GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.
Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
May 7, 2025Medical DevicesFDA
GE Medical Systems China Co., Ltd. recalls GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.
Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
May 7, 2025Medical DevicesFDA
GE Medical Systems China Co., Ltd. recalls GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.
Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
May 7, 2025Medical DevicesFDA
GE Medical Systems China Co., Ltd. recalls GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.
Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
May 7, 2025Medical DevicesFDA
GE Medical Systems China Co., Ltd. recalls GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.
Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
May 7, 2025Medical DevicesFDA
GE Medical Systems China Co., Ltd. recalls GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.
Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
May 7, 2025Medical DevicesFDA
GE Medical Systems China Co., Ltd. recalls GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.
Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
May 7, 2025Medical DevicesFDA
GE Medical Systems China Co., Ltd. recalls GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.
Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
May 7, 2025Medical DevicesFDA
GE Medical Systems China Co., Ltd. recalls GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
May 7, 2025Medical DevicesFDA
GE Medical Systems China Co., Ltd. recalls GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
Hazard: Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
April 30, 2025Medical DevicesFDA
Straumann USA LLC recalls WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
Hazard: Incorrect blister labelling.
April 30, 2025Medical DevicesFDA
Micro-X Ltd. recalls Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X
Hazard: Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
April 30, 2025Medical DevicesFDA
Micro-X Ltd. recalls Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rov
Hazard: Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
April 30, 2025Medical DevicesFDA
Remote Diagnostic Technologies Ltd. recalls Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007
Hazard: software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
April 30, 2025Medical DevicesFDA
Abbott Molecular, Inc. recalls The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall a
Hazard: The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.