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AMBU Hyperinflation System
WESTMED, INC. · Model 900 000 628 · UDI-DI 10889483528938
BZR
Prescription
10
510(k) clearances
590
Adverse events (9 deaths)
3
Recalls
40
Facilities
Description
Hyperinflation System, 1L Bag, 7' O2 and Manometer, 40 cm H2O Pop-Off Valve with Override
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-05-15 | CAREstream Medical LLC | Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing. |
| 2018-05-14 | O-Two Medical Technologies, Inc. | Higher levels of nitrous oxide delivered than specification |
| 2005-01-11 | Maquet Inc | Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality. |
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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.