Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-10-29FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IIElscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
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.
- 2025-10-29FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IIElscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
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.
- 2025-10-29FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IIElscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
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.
- 2025-10-29FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IIElscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
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.
- 2025-10-29FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IIElscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
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.
- 2025-10-29FDA-DeviceLeMaitre Vascular, Inc.Class IIArtegraft¿ Collagen Vascular Graft; REF: AG1015;
The device was incorrectly packed in the wrong size labeled outer packaging.
- 2025-10-29FDA-DeviceHeartSine Technologies LtdClass IIHeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
- 2025-10-29FDA-DeviceSEDECAL SAClass IISM_40HF_BDC3, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IISM_40HF_BDC, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IISM_40HF_B_D_VIR3.004, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IISM_40HF_B_D_VIR3, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IISHIMADZU RF.004, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IISED URS LP, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIRADPRO MOBILE, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
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.
- 2025-10-29FDA-DeviceSEDECAL SAClass IIModel Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
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.
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