FDA Device recall Z-1753-2013
Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company
- FDA Device
- Class II
- terminated
- Published 2013-07-24
On 2013-07-24 the FDA classified a Class II recall of Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company by Leibel Flarsheim, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1753-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-25 |
| Published | 2013-07-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Leibel Flarsheim |
| Distribution | US |
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.
Identifiers
| code_info | The following catalog numbers, serial numbers and associated manufacturing dates are affected by this recall: 700539 CI…The following catalog numbers, serial numbers and associated manufacturing dates are affected by this recall: 700539 CI0807H273 August2007; 700539 CI0106H162 January 2006; 700539 CI1010H523 October 2010; 700539 CI0811H567 August 2011; 700539 CI0108H313 January 2008; 700539 CI0309H418 March 2009; 700539 15031229 Apri12003; 700539 14031227 Apri12003; 700539 CI0404H045 January 2005; 700539 CI0504H054 May 2004; 700539 CI1106H208 November 2006; 700539 CI0509H424 May 2009 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1753-2013%22
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