AcQSim X-Ray Computed Tomography Scanners. These scanners were sold under the brand names: Picker, Marconi or Philips.
FDA Recall Z-0958-05 · Posted 2005-07-06
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Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2004-03-23
Date Terminated2012-03-02
Product Quantity44
Reason for Recall
Software anomaly in the DICOM Modality Worklist. When restoring a patient's images from the optical disk, images from the wrong patient may be displayed.
Firm Action
The firm mailed a ''Product Safety Notification'', dated 3/23/2004, to all users who had DICOM Modality Worklist enabled with a software key. The customers were notified of the problem and were provided instructions as to how to prevent the anomaly from occurring. The notification also informed the users that updated software which corrects the anomaly will be available in the near future and will be installed by the firm''s Field Service Engineers.
Root Cause
Other
Distribution Pattern
Nationwide and Austria, Italy, Netherlands, Spain, United Kingdom, and Sweden. The units were installed in medical facilities located in the following states within the U.S.: KS, PA, FL, MN, IA, CA, GA, LA, MS, OH, NE, MO, IN, TN, TX, MI, NM, MA, AL and NH;
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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