FDA Device recall Z-1988-2014
GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all gener…
- FDA Device
- Class II
- terminated
- Published 2014-07-09
On 2014-07-09 the FDA classified a Class II recall of GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all gener… by Ge Healthcare, citing 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 X….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1988-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-04 |
| Published | 2014-07-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Reason
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.
Identifiers
| code_info | Mfg Lot or Serial # System ID 00000023354HL4 804289HDFER 00000017868HL1 801268ER 00000024445HL9 804747DHPER 0000001…Mfg Lot or Serial # System ID 00000023354HL4 804289HDFER 00000017868HL1 801268ER 00000024445HL9 804747DHPER 00000018247HL7 972596PER3 00000021176HL3 804541ER 00000018523HL1 408977ER3 00000019915HL8 772468ER1 00000018898HL7 813571ERPRO 00000018576HL9 850747GCER 00000024536HL5 904391RAD1 00000019171HL8 561395RAD 00000020749HL8 773282TOMO8 00000034015HL8 847316PROER1 00000012567HL4 502868RAD2 00000017199HL1 972596OPRAD1 00000017648HL7 405271UPX1 00000032656HL1 407518PR1 00000041533HL1 580249SPRO2 00000022569HL8 614868PRO4 00000012718HL3 706257SFP 00000020559HL1 770748PER 00000033658HL6 704783PRO1 00000019846HL5 423493ER 00000031607HL5 605342RAD 00000012703HL5 915573RAD1 00000012705HL0 915573RAD2 00000020034HL5 410392R3 00000022299HL2 706554MSR1 00000003188HL2 901722RAD1 00000019209HL6 718780RAD1 00000011073HL4 865425RAD2 00000018254HL3 281338RAD 00000020919HL7 801292RM3 00000041379HL9 580249SPRO 00000038277HL0 408885SVC 00000029264HL9 561863RM6 0000003 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1988-2014%22
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