Z-0881-2013Class II

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

Name: Z-0881-2013 Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2012-10-24
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-10-24 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System on 2012-10-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0881-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-24
Posted: 2013-02-26
Terminated: 2015-07-23
Recalling firm: Philips North America LLC
Product: Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
Product code: JAK System, X-Ray, Tomography, Computed
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
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 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, VA, VT, WA, WI, and WV; Internationally to Canada and other countries..
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0881-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0880-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-26
Z-0881-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-26
Z-0882-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-26
Z-0883-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-26

Product code JAK

K012009Class IIMx8000 Idt CT SystemMarconi Medical Systems, Inc. / cleared 2001-09-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)