No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body
FDA device recall Z-2678-2014 · posted 2014-09-22 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JAX
- Quantity affected
- 61
- Distribution
- 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
- Date initiated
- 2007-01-09
- Date posted
- 2014-09-22
- Date terminated
- 2015-11-06
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACQSIM-MULTISLICE-CT, MODEL 453567042271 (K033357) | Philips Medical Systems (Cleveland), Inc. | 2004-01-09 |