Recall record at a glance
| Official record | Z-1753-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Leibel-Flarsheim Company LLC |
| Report date | Jul 24, 2013 |
| Recall initiation date | Apr 25, 2013 |
| Quantity | 12 units |
| Location | Cincinnati, OH, United States |
Official product description
Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
Why the product was recalled
A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. During the service call the systems Maximum Fluoro Dose was found to be 30 R/min which is three times the Maximum Fluoro Dose limit of 10 R/min.
Distribution information
Nationwide Distribution (US), including the states of TN, KY, CO, KS, CT, HI, and AZ.
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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