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.
FDA Recall Z-1019-2011 · Posted 2011-02-04
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Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeLLZ
Date Initiated2008-12-23
Date Terminated2011-08-25
Product Quantity686 units
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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