No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.
FDA Recall Z-2678-2014 · Posted 2014-09-22
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Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAX
Date Initiated2007-01-09
Date Terminated2015-11-06
Product Quantity61
Reason for Recall
When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.
Firm Action
Philips sent a Product Safety Notification letter dated December 21, 2006 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to distribute the Product Safety Notification to all affected users and keep a copy of the notification with the Instructions for Use until further notice. Customers with questions were instructed to contact Customer Care Center at 1-800-722-9377, option 5 - Diagnostic Imaging, option 1 - CT.
For questions regarding this recall call 440-483-7600.
Root Cause
Labeling design
Distribution Pattern
Worldwide Distribution - US including MO, TX, MD, AR, VA, KY, RI, NJ, MA, NY, LA, PA, VT, SC, CA, OH, FL, MN, MI and Internationally to Netherlands, Canada, Finland, Austria, France, Malaysia, Denmark, Norway, UK, Australia, Belgium, New Zealand.
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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