Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North
FDA device recall Z-0003-2009 · posted 2009-09-22 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- GE Healthcare has recently become aware of an error in the generator software on the Revolution XR/d configured with HP 8200 PC consoles that reports a mAs reading that is higher than is actually exposed to patients.
- Action taken
- Consignees were sent a GE Healthcare "Product Safety Notification" letter dated March 7, 2008. The letter was addressed to Hospital Administrators, Mangers of Radiology, and Radiologists. The letter listed the Safety Issue, Affected Product, Safety Instructions, and Contact Information.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 83 (63 USA, 20 OUS)
- Distribution
- Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, ID, IL, IN, LA, MA, MI, MO, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA, and WI and countries of Canada, China, Japan, Korea, and Taiw
- Date initiated
- 2008-02-14
- Date posted
- 2009-09-22
- Date terminated
- 2011-12-18
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS (K051967) | GE Healthcare | 2005-08-09 |