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

FDA device recall Z-1019-2011 · posted 2011-02-04 · Terminated

Recall details

Recalling firm

Philips Medical Systems North America Co. Phillips

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.

Action taken

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

Status

Terminated

Product code

LLZ

Quantity affected

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,

Date initiated

2008-12-23

Date posted

2011-02-04

Date terminated

2011-08-25

Location

Bothell, WA

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