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REAL Immersive System
PENUMBRA, INC. · Model RLE1-A · UDI-DI 00815948024229
0
510(k) clearances
0
Adverse events
3
Recalls
8
Facilities
Description
REAL i-Series
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-02-18 | Dollar Tree Distribution, Inc. | Potential exposure to rodents and rodent activity in the distribution center. |
| 2019-03-29 | Centurion Medical Products Corporation | Compromised seal on the sterile barrier pouch. |
| 2019-03-29 | Centurion Medical Products Corporation | Compromised seal on the sterile barrier pouch. |
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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.