Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW. Produ
FDA device recall Z-0187-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems. This check is being added to prevent a portion of the system falling onto the patient during a scan due to fasteners being loose that secure the camera to the gantry.
- 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
- 147
- 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 |