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BD Affirm™ VPIII Microbial Identification Test
BECTON, DICKINSON AND COMPANY · Model 446252 · UDI-DI 00382904462529
1
510(k) clearances
69
Adverse events
6
Recalls
4
Facilities
Description
BD Affirm™ VPIII Microbial Identification Test
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-08-28 | Physio Control, Inc. | This recall is being conducted due to the device being configured with the incorrect software for semi-automatic instead of fully automatic use. When the device is needed for a car |
| 2007-04-27 | Medtronic Emergency Response Systems, Inc. | White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up t |
| 2007-03-30 | Medtronic Emergency Response Systems, Inc. | Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery |
| 2007-03-30 | Medtronic Emergency Response Systems, Inc. | Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery |
| 2006-11-15 | MRL, Inc., A Welch Allyn Company | Shock Delay:The monitor-defibrillator may display an 'ECG Comm' error message on the display during use, which may prevent or cause an unacceptable delay the delivery of a defibri |
| 2006-06-30 | MRL, Inc., A Welch Allyn Company | The Welch Allyn PIC 50 Defibrillators may display a 'Defib Comm' or 'Pace Comm' error message on the device display during use which may result in a terminal failure of the device |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.