Recall record at a glance
| Official record | Z-2179-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | GE Healthcare, LLC |
| Report date | Jun 7, 2017 |
| Recall initiation date | Feb 6, 2017 |
| Quantity | 2,380 (2,215 US; 165 OUS) |
| Location | Waukesha, WI, United States |
Official product description
Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
Why the product was recalled
Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator.
Distribution information
US: Nationwide including DC and Puerto Rico. OUS: Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Egypt, France, Germany, Greece, Honduras, Hungary, Indonesia, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Libya, Malaysia, Malta, Mexico, Panama, Portugal, Russia, Saudi Arabia, Saudi Arabia, Slovakia, Spain, Thailand, United Arab Emirates, United Kingdom, Vietnam.
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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