26" Vision Elect HDTV Surgical Viewing Monitor, model number 0240030960, Manufactured by Stryker Endoscopy San Jose Inte
FDA device recall Z-0196-2009 · posted 2008-10-24 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- Knob parts stick together, resulting in poor functionality of the knob.
- Action taken
- Urgent: Device Correction letters dated 9/22/2008 were sent to Sales representatives and all accounts. Sales reps were also notified via email. Each Sales Rep was provided rework instructions, a list of affected accounts and serial numbers, and new knobs to install on affected units. Customers were asked to inspect their inventory for the part number, they were informed that their sales rep would be responsible for replacing the rotary knobs on all affected units, and that they should contact their sales rep to schedule the knob replacement.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 2265 devices
- Distribution
- Worldwide Distribution --- USA including states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentuc
- Date initiated
- 2008-09-22
- Date posted
- 2008-10-24
- Date terminated
- 2010-12-21
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER ENDOSCOPIC VIDEO ACCESSORIES (K935234) | Stryker Endoscopy | 1994-03-18 |