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Versius Insulating Sleeve Accessory Shipper Pack (Quantity 8 x 10022 in a shippe

CMR SURGICAL LIMITED · Model 10023 · UDI-DI 05060548211356

SCV
1
510(k) clearances
1,552
Adverse events
1
Recalls
16
Facilities

Recalls

DateFirmReason
2026-06-09CMR SURGICAL LIMITEDSecure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data 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.