Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
🏨
Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures.
Zavation
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal procedures.
Zavation
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Multitom RAX with software version VF10
Siemens Medical Solutions USA
Class I - Dangerous
Siemens identified two issues, In some cases, it is possible to perform an image acquisition although more than 20% of the beam does not hit the detector. This may only occur when an organ program for the wall mode without top alignment is selected and the system is moved to the centred position. If afterwards the operator activates the top alignment, increases the collimation, and lifts the tube, the system allows examination even with the tube being misaligned to the detector position. Hence, it is possible to overshoot the detector by more than 20%. From a clinical point of view, it is highly unlikely for the operator to trigger the examination as the misalignment is visible due to the light field being out of range. AND In very rare cases it may occur that the calculated dose value exceeds the limit of 2 Gy. This may potentially occur only when an organ program for free exposure is selected, and the system uses incorrect (too small) source-to-image distance (SID) for calculating applied dose. Hence, the calculated dose is much higher than the actual applied dose causing the buzzer, which normally notifies the operator about the exceeded limit of 2 Gy, to get activated erroneously.
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Fujifilm Medical Systems U.S.A.
Class I - Dangerous
Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic / spinal procedures.
Zavation
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.
Zavation
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / spinal procedures.
Zavation
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized
Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
Getinge (Suzhou) Co
Class I - Dangerous
There is a potential for abnormal inflation of the mattress.
Class I - Dangerous
Products distributed as sterile may not have been adequately sterilized