GE Healthcare Innova 3100 and Innova 3100 with Bolus Chasing offered as an option, Cardiovascular Imaging System.
FDA device recall Z-0897-06 · posted 2006-05-24 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient.
- Action taken
- GEHC is issuing a validated field action 3/6/2006 to correct the issues. Existing screws/bolts will be replaced using correct torque with screws containing cotter pins. Loctite liquid glue will be applied. Service manuals have been updated with instructions for using correct screws and torque. The field action is being implemented via Field Modification Instruction (FMI) 12033.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 300 (191 domestic and 109 OUS)
- Distribution
- Nationwide including Puerto Rico and OUS to include: Australia, Belgium, Brazil, Bulgaria, Byelarus, Canada, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece,
- Date initiated
- 2006-03-06
- Date posted
- 2006-05-24
- Date terminated
- 2008-02-24
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNOVA 3100 (K031637) | GE Medical Systems | 2003-08-22 |