Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain
FDA device recall Z-0673-2013 · posted 2013-01-17 · Terminated
Recall details
- Recalling firm
- Vycor Medical, Inc.
- Reason for recall
- Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
- Action taken
- Vycor Medical, Inc. notified all customers of the product recall by telephone and follow-up letter. Customers were instructed to quarantine affected products and hold the shipment(s) in quarantine unti further notice. The units will be replaced with inspected and passed units. All distributors were instructed to notify their customers of the recall and ask to have them return their stock. For question call 561-558-2020.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- GZT
- Quantity affected
- 3000 devices
- Distribution
- Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan.
- Date initiated
- 2012-08-21
- Date posted
- 2013-01-17
- Date terminated
- 2013-05-13
- Location
- Boca Raton, FL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VYCOR SURGICAL ACCESS SYSTEMS (K060973) | Vycor Medical, LLC | 2006-07-26 |