Recall Z-1753-2013— Leibel-Flarsheim Company LLC
Class II · Terminated
Class II FDA medical device recall by Leibel-Flarsheim Company LLC, initiated 2013-04-25, terminated 2013-07-26. It names one FDA 510(k) clearance: K943581. Product: Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.. Reason: 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..
- Recalling firm
- Leibel-Flarsheim Company LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-25
- Terminated
- 2013-07-26
- Firm location
- Cincinnati, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.