Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
FDA device recall Z-0002-2009 · posted 2009-09-24 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- GE Healthcare has recently become aware of a potential risk of observing a blank image after exposure on Revolution XR/d systems equipped with HP 8200 PC user consoles that may impact patient safety. It was reported that images acquired with off-center collimation for extremities with the position selected as Digits to front or Digits to back are displayed as blank. Investigation into th
- 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, Corrective Action and Contact Information.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 129
- Distribution
- Nationwide Distribution -- AL, AZ, CA, CO, FL, GA, HI, IL , IN, KY, LA, MD, MA, MI,MN,MS, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK OR, PA, SC, TN, TX, VA, WA, and WV.
- Date initiated
- 2008-02-14
- Date posted
- 2009-09-24
- Date terminated
- 2012-01-07
- 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 |