da Vinci Xi EndoWrist Suction Irrigator recall: Software Issue
da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and…
Why was da Vinci Xi EndoWrist Suction Irrigator recalled?
Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can experience unexpected motion of a system arm.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All
- Product
- da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and…
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 15 x 6 packs (90 units)
- Distribution
- US Only - one location each in AL, CO, KS, NV, NY, and 2 in TX
- Recall date
- April 19, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)