GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a
FDA device recall Z-2262-2012 · posted 2012-08-23 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye.
- Action taken
- An Urgent Safety Advisory Notice was sent to consignees on October 10, 2008. The letter identified the affected product and notified customers of the situation, along with instructing them to discontinue use until proper validation and instruction update for cable use was completed. GEHC OEC was to have contacted customers when the solution became available and resolved it at no cost to the customer.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OXO
- Quantity affected
- 149 units
- Distribution
- Nationwide distribution.
- Date initiated
- 2008-10-10
- Date posted
- 2012-08-23
- Date terminated
- 2013-01-10
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM (K041932) | Ge Oec Medical Systems, Inc. | 2004-08-18 |
| OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM (K024012) | Ge Oec Medical Systems | 2003-03-20 |
| OEC FLUOROTRAK 9800 PLUS (K022069) | Ge Oec Medical Systems | 2002-09-17 |
| OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM (K021049) | Ge Oec Medical Systems | 2002-04-17 |