GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System i
FDA device recall Z-0911-2014 · posted 2014-02-03 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems overhead LCD Video Monitor Suspension (Single monitor & Dual monitor). There is a potential for the locking nut to loosen out of the LCD Video Monitor Suspension yoke. This will not lead to an immediate fall of the suspended monitor since it will
- Action taken
- The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter dated December 11, 2013 to its consignees. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/ Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The consignees were instructed to immediately contact your local GE Healthcare Service Representative if you observe any inappropriate performance or excessive movement of the monitor suspension yoke. GE Healthcare will correct all affected systems at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call one of the following numbers: United States: 800-437-1171, Japan: 0120-055-919, for other countries contact your local GE Healthcare Service Representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 816 (722 US, 94 OUS).
- Distribution
- Worldwide distribution: US (nationwide) including Guam and DC but excluding CT, DE, HI and RI; and internationally to: AUSTRALIA, BULGARIA, CANADA, CHILE, DOMINICAN REPUBLIC, GERMANY, HONDURAS, IRELAN
- Date initiated
- 2013-12-12
- Date posted
- 2014-02-03
- Date terminated
- 2014-09-11
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS (K082243) | General Medical Merate S.P.A | 2008-11-07 |
| PRECISION 500D R&F X-RAY SYSTEM (K081091) | GE Healthcare | 2008-06-11 |
| GE PRECISION MPI (K033486) | Nrt-Nordisk Rontgen Teknik A/S | 2003-11-19 |