FDA Device recall Z-0881-2013
Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260
- FDA Device
- Class II
- terminated
- Published 2013-03-06
On 2013-03-06 the FDA classified a Class II recall of Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260 by Philips Medical Systems Cleveland, citing 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 s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0881-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-24 |
| Published | 2013-03-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
Product
Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
Reason
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
Identifiers
| code_info | The EBW Serial Numbers subject to software updates are as follows: 8222, 8235, 8270, 8838, 8841, 8862, 9014, 9019, 912…The EBW Serial Numbers subject to software updates are as follows: 8222, 8235, 8270, 8838, 8841, 8862, 9014, 9019, 9127, 10331, 10348, 10402, 10705, 10749, 10827, 11002, 11362, 11365, 11588, 11597, 11652, 11693, 11704, 11724, 11725, 11828, 11857, 11861, 11945, 11949, 11950, 11951, 11952, 11953, 11954, 11955, 11956, 11957, and 11979. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0881-2013%22
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