Reported Jul 9, 2014 · Terminated
GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system…
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, Revolution XR/d
- Revolution XR/d Intended UseThe Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications
- Lot codes and dates
- Mfg Lot or Serial # System IDCLAKEXRD 00000000002488 EBLUFFXRD
75 of 75 codes
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
JESSEBROWNADMIN799 of 799 codes
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
GRYPHONAURORA FMITR170990043 GRYPHONPROTEUS677 of 677 codes
FMITR170990065404501DICXRDFMITR170990067601883XRDFMITR170990128216844XRD3FMITR170990129715833XRDFMITR170990132415668XRD1FMITR170990135615264ER1FMITR170990153203576XRDFMITR170990154409772RS1FMITR170990160615896XR2FMITR170990161218249XRD1FMITR170990162218249XRD2FMITR170990163847677DRADFMITR170990167205592XRD2FMITR170990168205620SXRD1FMITR170990169208734IMXRDFMITR170990170210617H103FMITR170990171215710ER1FMITR170990172217876ER1FMITR170990173225765XRDFMITR170990174251990XRDFMITR170990175281929XRD1FMITR170990176301698XRDFMITR170990177303695XRDFMITR170990178310264XRDFMITR170990179312567XRD1FMITR170990180312567XRD2FMITR170990181314525SARM4FMITR170990182314525SARM6FMITR170990183314525SARM7FMITR170990184323268XRD1
548 of 548 codes
FMITR170990069082407020010FMITR170990070082407020015FMITR170990071082407020319FMITR170990072082407030314FMITR170990073082407040088FMITR170990074082407040236FMITR170990075082407040243FMITR170990076082407040244FMITR170990077082407040258FMITR170990078082407040267FMITR170990079082407040269FMITR170990080082407040274FMITR170990081082407060035FMITR170990082082407070063FMITR170990083082407070090FMITR170990084082407070091FMITR170990085082407090060FMITR170990086082407090094FMITR170990087082407090097FMITR170990088082407100120FMITR170990089082407100131FMITR170990090082407100132FMITR170990091082407100168FMITR170990092082407100170FMITR170990093082407100177FMITR170990094082407100178FMITR170990095082407100356FMITR170990096082407100358FMITR170990097082407110018FMITR170990098082407110050
- Mfg Lot or Serial # System ID
- Amount recalled
- 1053
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.
Want the full recall guide?
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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