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Thera-P
PIVOTAL HEALTH SOLUTIONS, INC. · Model PT9025 · UDI-DI 00850020142002
10
510(k) clearances
47
Adverse events (2 deaths)
2
Recalls
53
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-06-29 | ARJOHUNTLEIGH POLSKA Sp. z.o.o. | ArjoHuntleigh has concluded that a device tipping hazard may occur on the current Sara Combilizer lifting mechanism, providing a potential for risk to the patient or the caregiver. |
| 2009-01-26 | Phillips Nuclear Medicine | A problem has been identified with some upper patient pallets on Precedence SPECT/CT System, which may reduce its load bearing capacity and may result in its cracking. If this were |
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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.