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U.S. Department of Health and Human Services

Class 2 Device Recall 90JAK System, Computed Tomography Xray Scanning System

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 Class 2 Device Recall 90JAK System, Computed Tomography Xray Scanning Systemsee related information
Date Initiated by FirmMarch 23, 2004
Date PostedJuly 06, 2005
Recall Status1 Terminated 3 on March 02, 2012
Recall NumberZ-0957-05
Recall Event ID 30359
510(K)NumberK955268 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
ProductUltra Z 90 X-Ray Computed Tomography Scanners. These scanners were sold under the brand names: Picker, Marconi or Philips.
Code Information All devices manufactured between January 1996 and June, 2004 were subject to recall.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information ContactGeorge X. Kambic, Ph.D
440-483-2557
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionThe 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.
Quantity in Commerce44
DistributionNationwide 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;
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JAK
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