Precision 500D Classical R&F System with control room PC; Image-intensified fluoroscopic x-ray system; ; Model Number: 5
FDA device recall Z-0274-2008 · posted 2008-08-02 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Inaccurate cassette size display reading/ Inaccurate mAs reading: 1. When the device is in PBL mode and a larger film cassette is inserted into the table Bucky (replacing a smaller cassette) after a protocol is selected on the console, the collimator will not adjust to the larger cassette size. The collimator stays at the original smaller cassette size and allows the operator to take an exposure.
- Action taken
- Consignees were notified by two "Product Safety Notification" letters on July 10, 2007. Each letter addressed one of the two safety issues with the affected product. The letters provided safety instructions on how avoid the software error and informed users that their representative would contact them to schedule a visit for a software correction installation.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 101
- Distribution
- Worldwide Distribution --USA including states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, ID, IL ,IN, LA, MA, MD, MI, MO,MS, NC, ND, NE, NH, NJ, NM, NV, OH,OK, OR, PA, SC, SD, TN, TX, UT, VA, VT and WA; U
- Date initiated
- 2007-08-01
- Date posted
- 2008-08-02
- Date terminated
- 2008-09-10
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXPEDIO 500D R&F X-RAY SYSTEM (K011624) | GE Medical Systems | 2001-06-08 |