Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed

FDA device recall Z-0881-2013 · posted 2013-02-26 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Project

Action taken

Philips Medical issued an URGENT - Medical Device Correction letter to their customers concerning the Tumor LOC IPD issue on October 25, 2012. The letter informs the customer of the nature of this software problem and names the Brilliance and GEMINI scanning systems affected by this issue. The letter goes on to describe the hazard inherent to this software issue and provides 'Workaround procedures which the customers can use in order to help mitigate the effects of this problem. Customers with questions should contact their Customers Care Solutions Center at 1-800-722-9377, option 5. For questions regarding this recall call 1-800-722-9377.

Root cause

Software design

Status

Terminated

Product code

JAK

Quantity affected

39 units

Distribution

Worldwide Distribution - USA including AK, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, OA MA, MD MI, MN, MO, MS, NC, D, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT,

Date initiated

2012-10-24

Date posted

2013-02-26

Date terminated

2015-07-23

Location

Cleveland, OH

Related 510(k) clearances