Reported Mar 5, 2014 · Terminated
GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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 radiography exams, and specialized areas including pediatric work, intensive care and trauma, wherever conventional screen-film systems or CR systems may be used. The device is not intended for mammography or fluoroscopy applications.
- Lot codes and dates
- Mfg Lot or Serial # System IDSLWPRO
201 of 201 codes
00000007820HL1757736WDR100000075975HL3WDR1-RF100000075976HL1530BGDR00000075977HL9210MTFP00000075979HL5337470WDR200000075981HL1205408WDR100000075982HL9WDR1-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
DCHRMADIG305 of 305 codes
00000084554HL5330841PXD00000084556HL0330841RFD00000084989HL3409212GEDR100000085226HL9828456FLSHPD100000085228HL5732840WDRER100000085230HL1641228WDR100000085231HL9770400WDR100000085385HL3412367WDR00000085386HL1815395OSFER1D00000085387HL9SLWP50000000085389HL5732321WDR300000085494HL3330543WDR100000085496HL8404265FPAD100000085604HL7713SCFP00000085605HL4847872WDR100000085606HL2970945ORTHO00000085607HL0925370PRO100000085609HL6MH693WDR100000085927HL2713SCFP200000086214HL4731425TR3D00000086216HL9731425TR2D00000086217HL7636866DR100000086219HL3908522RM8WDR100000086463HL7508FHCMRAD00000086464HL5404501P50000000086465HL2507537WDR100000086466HL0937OVFLWD00000086629HL3636239DR100000086631HL9770968PRO00000086632HL7610861WDR1
FCLEWPROT71 of 71 codes
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
OVERPRO00000101087HL5757261RM1000000101089HL1301877RAD300000101137HL8MH693WDR200000101138HL6310374PRO00000101661HL7000411407100000101663HL3940384PRO00000101669HL0405372WDR100000101670HL8405372WDR100000101671HL6405949ER100000102207HL8
118 of 118 codes
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
- Mfg Lot or Serial # System ID
- Amount recalled
- 359 (333 US, 26 OUS).
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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