OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures durin
FDA device recall Z-2236-2012 · posted 2012-08-22 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- GE Healthcare had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to tip over when the arm of the imaging device is extended during use.
- Action taken
- GE Healthcare sent an "URGENT SAFETY ADVISORY NOTICE" dated October 11, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter stated that GEHC OEC Field Service Engineers would be contacting their facility to place a caution label on the articulating monitor arm of the cart and to provide a revised operators manual that will contain additional information on the safe usage of the cart. Until a GEHC Engineer had taken the actions described, they advised their consignees to exercise caution when fully extending the articulating monitor arm on the device to avoid potentially tipping over the cart. Contact the firm at 800-874-7378 for questions regarding this notice.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 99 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2006-10-11
- Date posted
- 2012-08-22
- Date terminated
- 2012-08-22
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500 (K003510) | Visualization Technology, Inc. | 2001-02-12 |