Z-1753-2013Class II

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

Name: Z-1753-2013 Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in...
Creator: Leibel-Flarsheim Company LLC
Published: 2013-04-25
License: https://open.fda.gov/license/

Mallinckrodt, Inc. / initiated 2013-04-25 / Terminated / root cause: manufacturing process

FDA source

Leibel-Flarsheim Company LLC began a recall of Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures on 2013-04-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1753-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-25
Posted: 2013-07-18
Terminated: 2013-07-26
Recalling firm: Mallinckrodt, Inc.
Product: Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 12 units
Distribution: Nationwide Distribution (US), including the states of TN, KY, CO, KS, CT, HI, and AZ.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1753-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1753-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-18

Product code OWB

K943581Class IIHydradjust IV Urological TableMallinckrodt Group, Inc. / cleared 1995-01-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)