Philips Medical Systems North America Co. Phillips 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Philips Medical Systems North America Co. Phillips
Lot Codes / Batch Numbers
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Products Sold
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Philips Medical Systems North America Co. Phillips is recalling PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Ph due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026