Varian brand GammaMed 12i Accessory: Clamping adapters for bronchial catheters, 1.8mm diameter, GammaMed 12i; Ref: BT-00
FDA device recall Z-0329-2012 · posted 2011-12-01 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- The Product Models 1 & 2 have a design flaw problem where the clamping adapter can obstruct movement of the source cable in the event the bronchial catheter is dislodged from the connector.
- Action taken
- Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION LETTER/FIELD SAFETY NOTICE" letter dated October 6, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Contact the Varian Help Desk at 1-888-827-4265 for questions regarding this notice.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAQ
- Distribution
- Worldwide Distribution--USA (nationwide).
- Date initiated
- 2011-10-06
- Date posted
- 2011-12-01
- Date terminated
- 2012-10-22
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GAMMAMED 12I (K891131) | Mick Radio-Nuclear Instruments, Inc. | 1989-08-07 |