Ingenia 1.5T, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Dr¿ger Perseus A500 Anesthesia Workstation
Draeger Medical
Class I - Dangerous
Unexpected shutdown while operating on battery power.
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
GYROSCAN T10-NT, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Intera 3.0T Quasar Dual, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Ingenia 3.0T, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Ingenia Ambition S, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Class I - Dangerous
Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device.
Intera 1.5T Master/Nova, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Ingenia 3.0T CX, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Class I - Dangerous
The product does not meet sterility assurance level.
Class I - Dangerous
Medical device components were marketed without FDA clearance
Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
Human Care Hc Sweden Ab
Class I - Dangerous
Patient lift hanger bar may come loose, which could potentially pose risks to patients.
Class I - Dangerous
Medical device components were marketed without FDA clearance and without FDA approval
Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard Specification for Adult Portable Bed Rails and Related Products and 16 CFR Part 1270, Safety Standard for Adult Portable Bed Rails ) and failed to meet all mandatory requirements outlined in these standards.
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266
Synovo Production
Class I - Dangerous
Medical device components were marketed without FDA clearance
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
RAYSEARCH LABORATORIES AB
Class I - Dangerous
A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.
Hemostasis Probe, Model: CD-B622LA
Olympus Corporation of the Americas
Class I - Dangerous
The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.