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REAL Immersive System
PENUMBRA, INC. · Model RLY1-A · UDI-DI 00815948024236
ISD
Prescription
10
510(k) clearances
34
Adverse events
2
Recalls
74
Facilities
Description
REAL y-Series
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-04-09 | BTE Technologies, Inc. | On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the Chop / Lift Bar could get accidently detached from the snap hook in specific use sc |
| 2013-12-03 | MedX Holdings, Inc. | Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing. |
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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.