Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Serial Numbers: 200005, 200013, and
FDA device recall Z-3209-2011 · posted 2011-09-14 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Software errors. Philips Medical's Field Service Engineers are installing software upgrades to certain of their Brilliance iCT and Brilliance ICT SP CT X-ray system units in order to correct non-conformances evidenced in these systems due to software errors.
- Action taken
- Philips Medical ( Cleveland) Inc. indicated in the Correction and Removal Report dated June 21, 2011, that a Philips Field Service Engineer will be contacting each site in order to schedule a time to implement the Field Change Order. After which time, the Field Service Engineer will visit each customer site to install the software upgrade and the firm will be tracking the progress of this corrective action. For further questions please call (440) 483-7000.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 3 units
- Distribution
- Worldwide Distribution -- USA (nationwide) including the states of DC, IL, IN, OH, PA and VT and the countries of Belgium and Israel.
- Date initiated
- 2011-06-15
- Date posted
- 2011-09-14
- Date terminated
- 2013-02-22
- Location
- Cleveland, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRILLIANCE VOLUME (K060937) | Philips Medical Systems (Cleveland), Inc. | 2006-06-05 |