Leibel-Flarsheim Company LLC: Medical Device Recall in 2013 - (Recall #: Z-1753-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.

Product Classification:

Class II

Date Initiated: April 25, 2013

Date Posted: July 24, 2013

Recall Number: Z-1753-2013

Event ID: 65176

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.

Status: Terminated

Product Quantity: 12 units

Code Information:

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

Distribution Pattern:

Nationwide Distribution (US), including the states of TN, KY, CO, KS, CT, HI, and AZ.

Voluntary or Mandated:

Voluntary: Firm initiated