Surgical robot console motors recalled over an error that locks ergonomics
Intuitive Surgical is recalling 144 da Vinci 5 Surgeon Console Column Motor Connectors because a connector fault triggers Error 23062 and locks console ergonomics until the motor is replaced.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states the fault may lead to a delayed, aborted or alternate procedure, and no injuries are reported.
Plain-English summary
The da Vinci 5 Surgeon Console Column Motor Connector, ASSY,DV5 CONSOLE,SSC,IS5000, part number 380730-40, is being recalled by Intuitive Surgical, Inc.
The record describes surgical system Error 23062 arising from the connector being either partially damaged, giving "Potential problem with ergonomics: Disable - Retry", or failed, giving "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable". Ergonomics remain locked until the motor is replaced, which the firm states may lead to a delayed, aborted or alternate procedure.
The record lists 144 units carrying UDI-DI 00886874119747, with serial numbers listed in the enforcement record including 10476314, 10485693 and 10496049. Distribution was nationwide in the United States across Minnesota, Florida, Colorado, California, North Carolina, Kansas, Texas, South Carolina, West Virginia, Louisiana, Ohio, New York, New Hampshire, Georgia, Kentucky, Oklahoma and New Jersey. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should follow Intuitive Surgical's instructions.
The recalled product
- Product
- da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical robot
- Affected units
- 144
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 00886874119747. Serial Numbers: 10476314
- 10485693
- 10496049
- 10497992
- 10503432
- 10503433
- 10507302
- 10509551
- 10511044
- 10511047
- 10516467
- 10518960
- 10518961
- 10522438
- 10522439
- 10522441
- 10523771
- 10523773
- 10523775
- 10523776
Distribution
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