Hydra Vision DR 60/80 System — Class II medical device recall Z-1753-2013
Terminated recall by Leibel-Flarsheim Company LLC, reported 2013-07-24, distributed nationwide. A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. Du
| Recall number | Z-1753-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leibel-Flarsheim Company LLC, Cincinnati, OH, United States |
| Recall initiated | 2013-04-25 |
| Classified | 2013-07-18 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2013-07-26 |
| Distributed | Nationwide (US) |
| Quantity | 12 units |
| Model numbers | 700539, 700540 |
Product
Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1753-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.