Philips Medical System Extended Brilliance Workspace — Class II medical device recall Z-0906-2013
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2013-03-13, distributed in AZ, CA, CO, CT, DC, FL, GA, HI…. Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the Extended Brilli
| Recall number | Z-0906-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2012-09-28 |
| Classified | 2013-03-05 |
| Reported by FDA | 2013-03-13 |
| Terminated | 2013-12-26 |
| Distributed | AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NV, NY, OH, OR, PA, PR, SC, TN, TX, VA, VT, WA, WI, WV |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, LB, LT, LV, MT, MX, MY, NG, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 2,580 units |
| Reason classes | software |
| Serial numbers | 10032, 10085, 10086, 10090, 10102, 10138, 10155, 10175, 10180, 10192, 10197, 10216, 10240, 10261, 10264, 10266, 10271, 10312, 10324, 10328, 10346, 10355, 10356, 10359, 10361 and 475 more |
| Model numbers | 728260 |
Product
Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Reason for recall
Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the Extended Brilliance Workspace (EBW) systems currently running software version(s) 4.0.2, V4.5.2 or V4.5.3, addressing a number of non-conformances.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0906-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.