Recall record at a glance
| Official record | Z-0010-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | GE Healthcare, LLC |
| Report date | Oct 8, 2014 |
| Recall initiation date | Sep 5, 2014 |
| Quantity | 204 (199 US, 5 OUS). |
| Location | Waukesha, WI, United States |
Official product description
GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations.
Why the product was recalled
GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging systems.
Distribution information
Worldwide Distribution - US Nationwide - AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI and in the countries CANADA, GERMANY, UNITED KINGDOM.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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