Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H31
FDA device recall Z-0189-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
- Action taken
- The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter, GEHC Ref# 40860, dated October 14, 2014 to its consignees. The letter described the Safety Issue, safety Instructions, Affected Product Details, Product Correction, actions to be taken and Contact Information. For questions, consignees in the United States, can contact 1-800-437-1171, for other countries they can contact their GE Healthcare Service Representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 22
- Distribution
- Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBI
- Date initiated
- 2014-10-14
- Date posted
- 2014-12-16
- Date terminated
- 2015-02-27
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA (K052434) | GE Medical Systems | 2005-09-27 |
| GE QUASAR NUCLEAR MEDICINE SYSTEM (K022960) | Ge Medical Systems F.I. Haifa | 2002-09-19 |
| HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA (K991841) | Ge Medical Systems F.I. Haifa | 1999-08-26 |