da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440;
FDA device recall Z-1819-2017 · posted 2017-04-13 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- 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.
- Action taken
- Firm sent e-mails on 3-17-17 to affected sites instructing them to STOP USE of the XI Suction Irrigator and RMA. and return all unused Xi Suction/irrigation instruments for credit. A formal letters was sent to affected sites on March 31, 2017. Letters advised of the reason for recall with details on product name and product number. Letters requested that any unused devices be returned to Intuitive via the standard RMA process. All personnel who use the Da Vinci system should be made aware of the issue. Response form should be completed online or by returning copy enclosed with the letter.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 15 x 6 packs (90 units)
- Distribution
- US Only - one location each in AL, CO, KS, NV, NY, and 2 in TX
- Date initiated
- 2017-03-31
- Date posted
- 2017-04-13
- Date terminated
- 2017-07-28
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EndoWrist Suction Irrigator (K162973) | Intuitive Surgical, Inc. | 2017-02-06 |