GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomogr
FDA device recall Z-0024-2014 · posted 2013-10-17 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID
- Action taken
- Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 26, 2013. The letter was addressed to Director of Radiology, Emergency Medicine Physicians and Radiologic Technologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 28 (4 US & 24OUS)
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, IS, LA, MA, MO, NH, NM, NY, OH, OK PA, SC, TX, UT, VA, WA, and WI, and the countries of UNITED KINGDOM, DENM
- Date initiated
- 2013-03-26
- Date posted
- 2013-10-17
- Date terminated
- 2013-12-05
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTIMA PET/CT 560 (K081496) | Ge Medical Systems, LLC | 2008-06-12 |