GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended for use in all routine rad
Check against the official notice below — it lists the full affected range.
GE Healthcare has issued a recall for GE Healthcare Precision 500D and Proteus XR/a radiographic imaging systems equipped with the Wireless Digital Radiography Option (WDR1) due to a software issue. When a large number of patient exams are retrieved from the HIS/RIS system, the exams may not display properly on the WDR1 device, which may impact patient safety. A total of 359 units have been affected worldwide, with 333 in the United States and 26 outside the United States, across multiple states and countries including Canada, the United Kingdom, Australia, and others.
The source document does not specify what remedy affected consumers should take or what steps they should follow regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare has recently become aware of a software issue associated with patient selection from the worklist on your WDR1(Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option) that may impact patient safety. Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the WDR1 are not properly displayed. I
Reason for recall: GE Healthcare has recently become aware of a software issue associated with patient selection from the worklist on your WDR1(Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option) that may impact patient safety. Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the WDR1 are not properly displayed. I Distribution: Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, DC, FL. GA, HI. IA, ID, IL, IN, LA, KY, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, TN ,KY, TX, UT, VA, WA, WV, WI and WY., and the countries of ARGENTINA, AUSTRALIA, CANADA, FRANCE, IRELAND, ITALY, JORDAN, ROMANIA, RUSSIA, UNITED ARAB EMIRATES and UNITED KINGDOM. Quantity: 359 (333 US, 26 OUS). Lot/code info: Mfg Lot or Serial # System ID 00000007820HL1 757736WDR1 00000075975HL3 WDR1-RF1 00000075976HL1 530BGDR 00000075977HL9 210MTFP 00000075979HL5 337470WDR2 00000075981HL1 205408WDR1 00000075982HL9 WDR1-RF2 00000075983HL7 337470WDR1 00000075984HL5 LLPM500D 00000076011HL6 434654RM4 00000076012HL4 585596FPD1 00000076013HL2 520GV500D 00000076014HL0 781624HSSHFP 00000076015HL7 954JDCHWDR1 00000076016HL5 503391SKY 00000076018HL1 954JDCHWDR2 00000076019HL9 518926DRRM4 00000076021HL5 954265WDR1 00000076022HL3 207795CM3WDR 00000076023HL1 719285P500 00000076026HL4 540DALEVILLE 00000076027HL2 410392RAD 00000076028HL0 318495WDR1 00000076285HL6 0002952447 00000076286HL4 918579PROTEUS 00000076287HL2 518926FLRM3 00000076288HL0 ORMCP500DIG 00000076290HL6 713791P500FP4 00000076379HL7 518243WDR1 00000076380HL5 504873FP1 00000076381HL3 435722GDXR 00000076487HL8 989224FLSHPD1 00000076489HL4 229924P500 00000076490HL2 405752RF2 00000076643HL6 COR481360 00000076644HL4 713UTPROTEUS 00000076646HL9 518243WDR1 00000076647HL7 706754EF1 00000076648HL5 COR481360 00000076649HL3 518243WDR1 00000076650HL1 918273CNNP1 00000076651HL9 918434P500 00000076652HL7 714827P500 00000076986HL9 325574WDRRM2 00000076990HL1 878WDR 00000076991HL9 919RALCPFLASH2 00000076995HL0 912384FP5 00000076996HL8 540829RF1DR 00000076997HL6 305LEON27FLGD 00000076998HL4 205877BPRF1 00000077642HL7 989224FLSHPD1 00000077644HL3 240566EDWDR1 00000077647HL6 925370PAD 00000077648HL4 603524500D 00000077649HL2 618443SFP 00000077652HL6 540CULRF2 0000
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.