Class I - Dangerous
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Baxter Healthcare
Class I - Dangerous
The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette.
Some anomalies have been identified during manufacturing controls.
Class I - Dangerous
Failure to comply with performance standard requirements (21 CFR 1040.10(f))when operated in the user accessible auto and music modes of operation
Class I - Dangerous
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.
Fujifilm Medical Systems U.S.A.
Class I - Dangerous
Fujifilm is reporting a corrective action due to an FDA inspection.
Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples.
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
Stanmore Implants Worldwide
Class I - Dangerous
Three (3) complaints were identified in which the potential for utilization of the JTS Grower Drive in the incorrect orientation in relation to the limb entry point of the device, together with the potential to select incorrect settings for the extension procedure. As a result, the prostheses in such cases failed to extend as intended.
Class I - Dangerous
There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Class I - Dangerous
Specific lots have been reported to produce falsely lower than expected results for Vitamin D
Class I - Dangerous
The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1Âŋ inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.
Class I - Dangerous
False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.
Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
Class I - Dangerous
False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.
Class I - Dangerous
False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.
Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples.