Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Philips North America
Class I - Dangerous
Customers were not notified of previous recalls associated with various defibrillator models.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Inpeco S.A.
Class I - Dangerous
The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result.
Class I - Dangerous
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
Class I - Dangerous
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Abbott Molecular
Class I - Dangerous
There is a potential for false positive results.
Class I - Dangerous
Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
Beckman Coulter
Class I - Dangerous
Missing splash guard which may expose users to hazardous materials. .
smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081
Smiths Medical ASD
Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084
Smiths Medical ASD
Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083
Smiths Medical ASD
Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Philips North America
Class I - Dangerous
Customers were not notified of previous recalls associated with various defibrillator models.
Class I - Dangerous
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101
Bio-Rad Laboratories
Class I - Dangerous
A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.
Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
Philips North America
Class I - Dangerous
Customers were not notified of previous recalls associated with various defibrillator models.
Class I - Dangerous
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
Class I - Dangerous
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.