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Showing 1841–1860 of 22584 results

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KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

KARL STORZ Pediatric Uretero-Renoscope (Karl Storz) – Reprocessing Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Moderate

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

EMPOWR 3D Knee Tibial Insert (Unknown) – Incorrect Sizing Risk (2024)

5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.

FDADec 18, 2024Nationwide

GE Healthcare Discovery NM 630 (GE Medical Systems) – Nuclear Medicine System Issue (2024)

GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

Stryker Blueprint Mixed Reality Pin Guide (Tornier) – Device Disassembly Risk (2024)

The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional.

FDADec 18, 2024AK, ID, KY +4 more• Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France

GE Healthcare Infinia I (GE Medical Systems) – Nuclear Medicine System Issue (2024)

GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

GE Healthcare Brivo NM 615 (GE Medical Systems) – Nuclear Medicine System Issue (2024)

GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

GE Healthcare Optima NM/CT 640 (GE Medical Systems) – Nuclear Medicine System Issue (2024)

GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

GE Healthcare Varicam Millennium (GE Medical Systems) – Nuclear Medicine System Issue (2024)

GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

Monitoring Service Application (Braemar) – ECG Event Processing (2024)

Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.

FDADec 18, 2024Nationwide• Braemar Manufacturing, LLC

HemosIL Heparin Calibrators (Instrumentation Laboratory) – Quality Control Problem (2024)

Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.

FDADec 18, 2024Nationwide• Instrumentation Laboratory

Olympus MAJ-891 Forceps/Irrigation Plug (Olympus) – Biomaterial Retention Risk (2024)

Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.

FDADec 18, 2024Nationwide• Olympus Corporation of the Americas

CODMAN CERTAS Plus Valve (Integra) – Incorrect Product Labels (2024)

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.

FDADec 16, 2024Nationwide• Integra LifeSciences Corp.

Medline Fluid Delivery Set (Medline) – Drip Chamber Mismatch (2024)

Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.

FDADec 16, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

LithoCrushV Mechanical Lithotriptor (Olympus) – Distal Tip Tearing (2024)

Potential for distal tip tearing of the Mechanical Lithotriptor V.

FDADec 16, 2024Nationwide• Olympus Corporation of the Americas

Hot Dog Patient Warming Mattress (Augustine) – Cable Connection Instability (2024)

There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.

FDADec 16, 2024Nationwide• Augustine Temperature Management, LLC

Calibrate CCX Interbody System (Alphatec) – Implant Collapse Risk (2024)

Complaints have been received regarding post-operative implant collapse.

FDADec 15, 2024Nationwide• Alphatec Spine, Inc. 1950 Camino Vida Roble

Panther Fusion GBS Assay (Hologic) – Pouch Seal Weakness (2024)

Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.

FDADec 13, 2024AR, CA, CT +17 more• Hologic, Inc.

IMed Dressing Change Kit (Trinity Sterile) – Package Sterility Risk (2024)

Potential for hole in package compromising sterility of the medical kit.

FDADec 13, 2024Nationwide• Trinity Sterile, Inc.

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