Reported Jul 9, 2014 · Terminated
GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human…
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, Proteus XR/a
- Proteus XR/a Intended UseIs intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications
- Lot codes and dates
- Mfg Lot or Serial # System ID
2,427 of 2,427 codes
00000023354HL4804289HDFER00000017868HL1801268ER00000024445HL9804747DHPER00000018247HL7972596PER300000021176HL3804541ER00000018523HL1408977ER300000019915HL8772468ER100000018898HL7813571ERPRO00000018576HL9850747GCER00000024536HL5904391RAD100000019171HL8561395RAD00000020749HL8773282TOMO800000034015HL8847316PROER100000012567HL4502868RAD200000017199HL1972596OPRAD100000017648HL7405271UPX100000032656HL1407518PR100000041533HL1580249SPRO200000022569HL8614868PRO400000012718HL3706257SFP00000020559HL1770748PER00000033658HL6704783PRO100000019846HL5423493ER00000031607HL5605342RAD00000012703HL5915573RAD100000012705HL0915573RAD200000020034HL5410392R300000022299HL2706554MSR100000003188HL2901722RAD100000019209HL6718780RAD1
- Mfg Lot or Serial # System ID
- Amount recalled
- 3460
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. . There was a reported incident of a collimator fall which caused a serious patient injury.
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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