Brilliance 64 Computed Tomography System, Model #78231, Serial Number: 9592. The Brilliance 64 is a Computed Tomography
FDA device recall Z-3281-2011 · posted 2011-09-27 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Component defect. Philips Medical decided to conduct a recall field /correction (rework) of the mounting key locking threaded insert of the Detector Module system (DMS) bolt on one (1) Brilliance 64 CT X-ray unit. The firm initiated this action following Philip's receipt of the customer's complaint reporting that the retaining inserts were pulling out of the rotor during the removal of the UDMS
- Action taken
- Philips sent a Field Change Order (FCO) 72800519 on June 13, 2011 to the affected customer. A Field Service Engineer visited the customer site and installed a hardware upgrade to the affected Brilliance 64 device system (Serial Number: 9592). The correction action was completed on August 9, 2011. For questions regarding this recall call 1-440-483-7000.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 1 unit
- Distribution
- Nationwide Distribution including PA
- Date initiated
- 2011-06-02
- Date posted
- 2011-09-27
- Date terminated
- 2013-03-15
- 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 |