GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR
FDA device recall Z-1078-2014 · posted 2014-02-24 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of a software issue associated with patient selection from the worklist on your WDR1(Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option) that may impact patient safety. Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the WDR1 are not properly displayed. I
- Action taken
- GE Healthcare sent an "Urgent Medical Device Correction" letter dated January 20, 2014. The letter was addressed to Hospital Administrators / Risk Mangers, Radiology Department Mangers and Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information ( In USA call 800-437-1171, For other countries contact your local GE Healthcare Service Representative).
- Root cause
- Software design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 359 (333 US, 26 OUS).
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, DC, FL. GA, HI. IA, ID, IL, IN, LA, KY, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA
- Date initiated
- 2014-01-20
- Date posted
- 2014-02-24
- Date terminated
- 2014-11-03
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WIRELESS DR IMAGING OPTION-WDR1 (K102615) | Ge Medical Systems, LLC | 2010-11-18 |