Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130,
FDA device recall Z-0360-2012 · posted 2011-12-02 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Software errors. A number of non-conformances were logged during in-house testing and external validation testing of Brilliance 64 and Ingenuity CT software version 4.0 Beta 2. The non-conformances are due to software errors identified in these device systems.
- Action taken
- Philips Healthcare released a 'Field Change Order' (FCO #72800542) on September 15, 2011. Philips sent an URGENT - Medical Device Correction letter dated October 10, 2011, to all affected customers. The letter listed the affected device systems; described the nature of the software problem; and any possible hazard inherent to the situation. The letter was mailed by Philips to their customers on October 27, 2011. The letter provided information telling the customer how to identify the affected products and what action to take. In this instance, the customer was asked to review the Customer Release Notes which were provided to each customer location once the software update was installed. The letter notified the customer that a Philips representative would be installing a software upgrade in order to address the referenced software issues free-of-charge, through a Field Change Order. The letter closes by providing information which all customers in Canada and North America can use to contact the firm through a toll-free telephone number 1-800-722-9377, option 5; enter side ID or follow the prompts. For questions regarding this recall call 440-483-4918.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 5 units
- Distribution
- Worldwide Distribution - USA including Ohio and the countries of Australia, China, Belgium, Israel, and Sweden
- Date initiated
- 2011-09-06
- Date posted
- 2011-12-02
- 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 |