October 29, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Hazard: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
October 29, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Hazard: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
October 29, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Hazard: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
October 29, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Hazard: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
October 29, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Hazard: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
October 29, 2025Medical DevicesFDA
LeMaitre Vascular, Inc. recalls Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Hazard: The device was incorrectly packed in the wrong size labeled outer packaging.
October 29, 2025Medical DevicesFDA
HeartSine Technologies Ltd recalls HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
Hazard: Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls SM_40HF_BDC3, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls SM_40HF_BDC, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls SM_40HF_B_D_VIR3.004, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls SM_40HF_B_D_VIR3, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls SHIMADZU RF.004, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls SED URS LP, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls RADPRO MOBILE, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
October 29, 2025Medical DevicesFDA
SEDECAL SA recalls Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Hazard: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.