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ACIST RXi® System and Accessories
ACIST MEDICAL SYSTEMS, INC. · Model 014666 · UDI-DI 40841716100732
OBI
Prescription
1
510(k) clearances
22
Adverse events (1 deaths)
1
Recalls
3
Facilities
Description
RXi System Overpack, p/n 801027-001 Contents: Console, Power Supply, Bed Mount, USB Drive, and Accessory Box (Cables)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-03-13 | Merit Medical Systems, Inc. | The products are labeled as sterile but were not sterilized. |
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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.