Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imagi
FDA device recall Z-1753-2013 · posted 2013-07-18 · Terminated
Recall details
- Recalling firm
- Leibel-Flarsheim Company LLC
- 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.
- Action taken
- The customers received an "Urgent Device Correction" notification letter on May 12, 2013 explaining the product issue and providing recommended actions. Customers were contacted to set up a service call to test and recalibrate equipment as necessary. Questions were directed to 800-778-7898.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 12 units
- Distribution
- Nationwide Distribution (US), including the states of TN, KY, CO, KS, CT, HI, and AZ.
- Date initiated
- 2013-04-25
- Date posted
- 2013-07-18
- Date terminated
- 2013-07-26
- Location
- Cincinnati, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYDRADJUST IV UROLOGICAL TABLE (K943581) | Mallinckrodt Group, Inc. | 1995-01-04 |