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FDA device recall Z-0950-2013 · posted 2013-03-14 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- This field change order is being released to update software and customer release notes to the affected installed base.
- Action taken
- Philips Healthcare sent an Urgent Medical Device Correction letter dated February 13, 2013, via certified mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review the information contained in the letter with all members of their staff who need to be aware of the contents of the letter. Customers were instructed to retain a copy with the equipment Instruction for Use. For questions customers were instructed to contact their local Phillips representative or local Philips Healthcare office. For North Americal and Canada contact Customer Care Solutions Center at 1-800-722-9377, option 5: Enter Site ID or follow the prompts For questions regarding this recall call 1-800-722-9377.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 42 Units
- Distribution
- Worldwide Distribution - USA including AR, AZ, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, WY, and worldwide including the contries of Australia, Belgium, China, France, German
- Date initiated
- 2013-02-15
- Date posted
- 2013-03-14
- Date terminated
- 2014-04-11
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM (K033326) | Philips Medical Systems, Inc. | 2003-10-29 |