Z-1019-2011

PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Philips...

Name: Z-1019-2011 PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Philips...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2008-12-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-12-23 / Terminated / root cause: software

FDA source

Philips Medical Systems North America Co. Phillips began a recall of PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Philips Electronics... www.medical.philips.com... Philips... on 2008-12-23. The reason FDA records is "There is a risk of selecting the wrong patient, when patient is selected in the patient list and the examination tab pressed with background query are running at the same time". 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-1019-2011
Status: Terminated
Initiated: 2008-12-23
Posted: 2011-02-04
Terminated: 2011-08-25
Recalling firm: Philips North America LLC
Product: PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Philips Electronics... www.medical.philips.com... Philips Medical Systems Nederland B.V". Provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: There is a risk of selecting the wrong patient, when patient is selected in the patient list and the examination tab pressed with background query are running at the same time.
Root cause tag: software
FDA root cause: Software design
Action: On 1/30/2009, Philips began sending out URGENT-Device Correction PCR Eleva notifications to their consignees. The consignees were informed of the hazards as when a patient is selected in patient list and examination tab pressed with background query running at the same time, there would be a risk that the wrong patient is selected. The firm issued the Field Corrective Order (FCO) 73200029 to their representative to correct the problem. The corrective action would be a software upgrade that resolve the issue. All consignees can contact Philips Call Center at 800-722-9377, #5, #2 and reference "FCO 73200029" with any questions.
Quantity in commerce: 686 units
Distribution: Nationwide Distribution -- USA, including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WI, WV, and WY and to LANDSTUHL ARMY BASE, APO in United Arab Emirates.
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Product code LLZ

K964124Class IIPhilips Computed RadiographyPhilips Medical Systems, Inc. / cleared 1996-12-18

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)