FDA Device recall Z-1248-2015
GE Healthcare Proteus XR/a with wall stand model number 2260354
- FDA Device
- Class II
- terminated
- Published 2015-03-18
On 2015-03-18 the FDA classified a Class II recall of GE Healthcare Proteus XR/a with wall stand model number 2260354 by Ge Healthcare, citing potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use co….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1248-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-30 |
| Published | 2015-03-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare Proteus XR/a with wall stand model number 2260354. 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
Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use could result in an injury to a patient or operator.
Identifiers
| code_info | Mfg Lot or Serial # System ID 00000014277HL8 503246PRO 00000014127HL5 202715PRO 00000013133HL4 206215RM1 0000001308…Mfg Lot or Serial # System ID 00000014277HL8 503246PRO 00000014127HL5 202715PRO 00000013133HL4 206215RM1 00000013085HL6 206543HECED 00000014123HL4 208785RAD 00000014689HL4 208882GX1A 00000010591HL6 208893RAD2 00000014556HL5 209943SJRM2 00000013410HL6 214320RAD1 00000014413HL9 215918RAD1 00000014555HL7 215918RAD1 00000014684HL5 215918RAD2 00000014116HL8 216343R3 00000014276HL0 216343R4 00000013780HL2 217258SR3 00000024745HL2 217333LXR2 00000014020HL2 219284PRO1 00000014687HL8 225638R1 00000014119HL2 248652PROT3 00000014679HL5 262321RAD1 00000015410HL4 281392PRO 00000014424HL6 304257PROT 00000011358HL9 304354PROD 00000015166HL2 309655FNCR1 00000015168HL8 309655FNCR2 00000012515HL3 313369PROT 00000013910HL5 314768MRM8 00000014562HL3 314966JRM2A 00000011363HL9 318425LR1 00000013785HL1 319382PROTXR 00000014412HL1 330270PX 00000015409HL6 330438R3 00000014282HL8 330489XR3 00000014423HL8 330675PX 00000011060HL1 336768OSAB 00000010841HL5 336768OSCD 000000110 |
|---|
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-1248-2015%22
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