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Health product recall

Kodak Directview DR 7500 system (2014-07-11)

Starting date:
July 11, 2014
Posting date:
July 22, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-40611

Recalled Products

Kodak Directview DR 7500 system 

Reason

Carestream has identified an issue at a customer site related to the DR 7500 Beta Assembly (X-ray tube and collimator) detaching from the overhead tube crane (OTC) telescope. It has been determined that as a result of an improperly assembled part which holds the beta assembly to the OTC telescope, an inspection of the part is needed, and in addition, a repair of the assembly may be required.

Affected products

Kodak Directview DR 7500 system 

Lot or serial number
  • 75000150
  • 75000216
  • 75000233
  • 75000590
  • 75000648
  • 75000673
Model or catalog number

879 1345

Companies
Manufacturer
Carestream Health Inc.
150 Verona Street
Rochester
14608
New York
UNITED STATES