Class II — Philips Medical Systems (Cleveland) Inc
| Recalling firm | Philips Medical Systems International BV |
|---|---|
| Registered facility | View this company's 54 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 2,580 units |
| Distribution | Worldwide Distribution - USA including the states of AL, AT, AZ, BAH, 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, PR, SC, TN, TX, VA, VT, WA, WI & WV. and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Columbi… |
| Initiated | 2012-09-28 |
| Classified | 2013-03-05 |
| Terminated | 2013-12-26 |
| Recall number | Z-0906-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Philips Medical Systems (Cleveland) Inc (Z-0906-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64259/
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