Class I - Dangerous
Potential for a transducer mis-alignment in certain transvaginal probes.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations.
Class I - Dangerous
The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.
The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations.
TAPSYSTEM Model 2A, REF 8002A
Cardiocommand
Class I - Dangerous
There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly.
Class I - Dangerous
The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.
Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664
Olympus Corporation of the Americas
Class I - Dangerous
WM-NP/DP2 workstations could become unstable and may fall over if the control panel arm is mounted with a video monitor weighing more than 19.8 pounds.
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Philips North America
Class I - Dangerous
The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption of monitoring and failure or delay in the delivery of a shock or pacing can occur. A faulty AC Power Module may also fail to charge the battery.
Cios care fusion system
Siemens Medical Solutions USA
Class I - Dangerous
DAP chamber may be missing an insulating foil
Cios Alpha VA20/ VA30 mobile X-Ray systems
Siemens Medical Solutions USA
Class I - Dangerous
DAP chamber may be missing an insulating foil
The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle.
The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle.
Class I - Dangerous
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135
Siemens Medical Solutions USA
Class I - Dangerous
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Number: 10848283
Siemens Medical Solutions USA
Class I - Dangerous
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
Class I - Dangerous
When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Bio-Rad Laboratories
Class I - Dangerous
User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests/results properly and may contribute to transmitting erroneous results to the customer's Laboratory Information System (LIS).
Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number: 10848280
Siemens Medical Solutions USA
Class I - Dangerous
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281
Siemens Medical Solutions USA
Class I - Dangerous
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141
Siemens Medical Solutions USA
Class I - Dangerous
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel