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Terminated

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

FDA Recall Z-1753-2013 · Posted 2013-07-18

Recalling FirmLeibel-Flarsheim Company LLC
Recall StatusTerminated
Product CodeOWB
Date Initiated2013-04-25
Date Terminated2013-07-26
Product Quantity12 units

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.

Firm 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.

Root Cause

Employee error

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K943581HYDRADJUST IV UROLOGICAL TABLEMallinckrodt Group, Inc. · 1995-01-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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