Class I - Dangerous
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).
Shanghai United Imaging Healthcare Co.
Class I - Dangerous
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
Class I - Dangerous
Due to false positive results.
Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).
Shanghai United Imaging Healthcare Co.
Class I - Dangerous
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).
Shanghai United Imaging Healthcare Co.
Class I - Dangerous
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
Merete Medical GmbH
Class I - Dangerous
Product may be mislabeled.
Class I - Dangerous
There is a potential for fire in the inside computer cabinet.
When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.
Class I - Dangerous
The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were designed with a short creepage distance of 1.8 mm between the two distinct and proximal areas on the printed circuit board (PCB) where as the standard requires a creepage distance of 4 mm.
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
Merete Medical GmbH
Class I - Dangerous
Product may be mislabeled.
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001
Stryker Instruments Div. of Stryker
Class I - Dangerous
Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.
OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
Merete Medical GmbH
Class I - Dangerous
Product may be mislabeled.
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
Merete Medical GmbH
Class I - Dangerous
Product may be mislabeled.
Class I - Dangerous
The product did not receive pre-market approval or clearance.
Class I - Dangerous
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Class I - Dangerous
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Class I - Dangerous
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Class I - Dangerous
Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated, the needle can fall out of the sheath and cause the unused needle to project out of the cartridge, and result in a needle stick/puncture from the clean/unused needle
Class I - Dangerous
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Class I - Dangerous
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.