Reported Jul 1, 2026 · Ongoing
Da Vinci ASSY, PSS, SP1098, Part Number: 380601
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd · Sunnyvale, CA · 94086-5304
Is this the product you have?
- Da Vinci ASSY, PSS, SP1098
- Part Number380601
- Lot codes and dates
- UDI00886874114605
- Serial Numbers
454 of 454 codes
60540860684861232862839960935361407361779461676910008062635659631694638771641430694998645433643209954097656203764644656319946098667190666480655562664662680530679266683974674171676962682694686777701248696877688725688225697922700316698277702699709536701751717804705366704731724178703152722803693262736468736338740359742366732233696089724835716520709987728391751529
- Amount recalled
- 454
Where it was sold
Why it was recalled
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.
This product could cause temporary or reversible health problems — stop using it.
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