GE HealthCare Medical Device Recall Event Report

Internal Recall Number: FMI 63003

Product Information

Product Name: Magnetic Resonance Imaging System

Registration/Filing Certificate Number: 国械注准 20203060863

Manufacturer: General Electric Medical Systems (Tianjin) Co., Ltd.

Product Scope of Application: Clinical MRI diagnosis

Involved Regions and Countries: China

Recall Level: Level 2

Product Model/Specification: SIGNA Architect AIR

Quantity Involved (Production/Imported): 184 units

Sales Quantity in China: 184 units

Recall Details

Recall Reason: GE HealthCare recently discovered that for some SIGNA Architect AIR MR systems, the maintenance (PM) procedure performed on or after March 1, 2023, may not have included the inspection of the scanner bed wheel lock function. This inspection is intended to proactively identify potential malfunctions of the scanner bed wheel lock, preventing accidental movement of the scanner bed when it is not docked with the system. No patient injuries have been reported due to this issue. To maintain high standards of safety and quality, GE HealthCare has decided to proactively recall and provide free correction for this potential product issue for affected customers.

Corrective Actions:

GE HealthCare will notify customers about this issue and precautions.
GE HealthCare will dispatch engineers to customer sites to re-inspect the scanner bed wheels.

Note: This corrective action does not involve the suspension or return of the affected products.

Identification Information

Refer to Appendix 2 for detailed identification information (serial numbers).

Serial Number	Serial Number	Serial Number	Serial Number	Serial Number	Serial Number	Serial Number	Serial Number	Serial Number	Serial Number
082427210238	082427090465	082427100482	082427120357	082427140330	082427040281	082427030230	082427160358	082427110160	082427250132
082427210236	082427090477	082427100469	082427120350	082427140340	082427040279	082427030218	082427160409	082427200214	082427250121
082427210257	082427090457	082427100447	082427120277	082427210223	082427090479	082427100491	082427120364	082427210250	082427090446
082427100450	082427120351	082427140308	082427040333	082427140353	082427060125	082427140346	082427080125	082427060120	082427160408
082427110161	082427250138
082427090488	082427090459	082427100518	082427120337	082427140310	082427070278	082427060112	082427030219	082427030204	082427090438
082427090471	082427100486	082427120344	082427140303	082427160403	082427230259	082427160402	082427230226	082427170042	082427230270
082427080142	082427030196	082427190195	082427230234	082427250118
082427090432	082427090481	082427100442	082427120284	082427140317	082427080145	082427090475	082427100496	082427100484	082427120372
082427050061	082427080127	082427090437	082427100480	082427150127	082427120349	082427040299	082427080144	082427160405	082427030223
082427190196	082427230196	082427160360	082427190206	082427230241	082427110155	082427230220
082427090469	082427100487	082427150132	082427120302	082427070256	082427080139	082427160407	082427110144	082427230236
082427090491	082427100445	082427150129	082427120353	082427070263	082427070342	082427160429	082427110151	082427220121
082427090470	082427100446	082427150130	082427120377	082427070331	082427070357	082427160433	082427200219	082427220118
082427040320	082427100431	082427150131	082427120303	082427050063	082427070290	082427160396	082427200224	082427220122
082427090464	082427100521	082427150140	082427130129	082427070322	082427020112	082427160393	082427200207	082427220140
082427090479	082427100497	082427150128	082427130144	082427070358	082427020129	082427160339	082427200207	082427220140
082427090487	082427100459	082427120327	082427130176	082427070314	082427010214	082427180085	082427160361	082427200233	082427310172
082427090467	082427100504	082427120343	082427090461	082427100451	082427120360	082427130155	082427040302	082427020126	082427200210
082427310170	082427160438	082427100493	082427120295	082427130156	082427040308	082427010187	082427200203	082427030207	082427160349
082427200199	082427250136

Reporting Information

Responsible Person: Zhang Yun

Contact Number: 18910727377

Report Date: July 23, 2025

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Product Information

Recall Details

Identification Information

Reporting Information

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