Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-s
FDA device recall Z-1718-2014 · posted 2014-06-04 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.g. scraping, squeaking, rattling), cracks or vibration in the system.
- Action taken
- Intuitive sent an Urgent Medical Device Correction letter dated May 13, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. All personnel who use the device should be notified of the issue and the acknowledgement form completed and returned. Intuitive reps will visit each affect sites to install a replacement PSC and ensure that it is properly integrated with the Da Vinci. For questions contact Intuitive Surgical at 800-876-1310 Option 3 (Monday - Friday 6 am to 5 pm PST).
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 2
- Distribution
- Medical facilities in TX and FL
- Date initiated
- 2014-05-09
- Date posted
- 2014-06-04
- Date terminated
- 2014-06-04
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES (K131861) | Intuitive Surgical, Inc. | 2014-03-28 |