510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-0738-2007

Kodak Direct View DR7500 System, Catalog #s 855-1046, 879-1345, 161-9139 --- A stationary X-Ray System...

Eastman Kodak Company / initiated 2007-03-06 / Terminated
FDA source (opens on fda.gov)

Carestream Health, Inc. began a recall of Kodak Direct View DR7500 System, Catalog #s 855-1046, 879-1345, 161-9139 --- A stationary X-Ray System. Device Listing # E222512 on . The reason FDA records is "The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0738-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Eastman Kodak Company
Product
Kodak Direct View DR7500 System, Catalog #s 855-1046, 879-1345, 161-9139 --- A stationary X-Ray System. Device Listing # E222512.
Product code
KPR System, X-Ray, Stationary
Reason for recall
The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21Code of Federal Regulations (CFR).
FDA root cause
Other
Action
On 2/21/07, Eastman Kodak notified CDRH of its proposed Corrective Action Plan CAP). The CAP was approved by CDRH under the following conditions: (1) Kodak will visit each user facility, and apply dial indicator labels to the collimator knobs, apply a field size label to the collimator housing, and verify that each system complies with the field indication performance standard. (2) Kodak will prepare adequate instructions for the assembly/installation and testing of the dial indicators labels and field size labels. These instructions are to be furnished to all owners of the Kodak Direct View DR 7500 Systems. (3) Kodak will supplement the Kodak DR 7500 system product report with a copy of the adequate instructions. (4) Kodak will perform 100% verification of the recall effectiveness. (5) Kodak will not charge for the corrections and will reimburse the owner for any out-of-pocket expenses. (6) Kodak will notify the manufacturer of the Ralco 302 ACS collimators, Ralco, that the collimator is noncompliant with the performance standard. Kodak has reported that the CAP was completed as of 5/07/07.
Quantity in commerce
Domestic: 28 units
Distribution
Nationwide: CO, IL, MI, MN, MS, NY, OK, PA, SC, TN, WA
Product codes and lots
Serial Numbers DR75000103, DR75000110, DR75000123, DR75000125, DR75000126, DR75000129, DR75000133, DR75000134, DR75000135, DR75000138, DR75000139, DR75000141, DR75000144, DR75000145, DR75000147, DR75000202, DR75000203, DR75000205, DR75000206,  DR75000210, DR75000213, DR75000219, DR75000220, DR75000221, DR75000232, DR75000250, DR75000252, DR75000258.