FDA Medical Device Recalls (openFDA)
Leibel-Flarsheim Company LLC: Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
- Recall number
- Z-1753-2013
- Recalling firm
- Leibel-Flarsheim Company LLC
- Product
- Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
- Status
- Terminated
- Initiated
- 2013-04-25
- Posted
- 2013-07-18
- Terminated
- 2013-07-26
- 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.
- Root cause
- Employee error
- Action
- 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.
- Quantity
- 12 units
- Distribution
- Nationwide Distribution (US), including the states of TN, KY, CO, KS, CT, HI, and AZ.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K943581"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 1518293
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28