The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended t
FDA device recall Z-2404-2012 · posted 2012-09-19 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button.
- Action taken
- Philips sent an Urgent - Medical Device Correction letter dated August 24, 2012 via certified mail to all US consignees. Philips Key Market representatives distributed the letter internationally. The letter identified the affected product, problem and actions to be taken by customer/user. Philips is implementing a software update to correct the issue free of charge. A Philips representative will contact affect sites to schedule the software installation. For further information or support contact your Philips representative or local Philips Healthcare office.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 93 units
- Distribution
- Worldwide Distribution - US Nationwide including the states of: AL, CA, GA, MA, MD, NC, OH, PA, TX, and WA; and to the following countries of: Algeria, Oman, Australia, Brazil, China, Saudi Arabia, Un
- Date initiated
- 2012-08-28
- Date posted
- 2012-09-19
- Date terminated
- 2013-12-24
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MX8000 IDT CT SYSTEM (K012009) | Marconi Medical Systems, Inc. | 2001-09-13 |