Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Wo
FDA device recall Z-0906-2013 · posted 2013-03-05 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- 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.
- Action taken
- Philips Healthcare sent a Urgent Medical Device Correction letter dated September 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. This Field Safety notification is to inform the actions that should be taken by the customer/user to prevent risks for patient or users, and the actions planned by Philips to correct the problem. If you need further information or supplies please contact your local Philips Healthcare office. For North American and Canada contact the Customer Care Solutions Center ( 1-800 722-9377) option 5 enter site or follow the prompts.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 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
- Date initiated
- 2012-09-28
- Date posted
- 2013-03-05
- Date terminated
- 2013-12-26
- Location
- Cleveland, OH
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| SELECT/SP (K961464) | Elscint, Inc. | 1996-07-03 |