| | Class 2 Device Recall GE Healthcare |  |
| Date Initiated by Firm | October 28, 2024 |
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| Date Posted | November 22, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0519-2025 |
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| Recall Event ID |
95735 |
| 510(K)Number | K160618 K163331 K202966 |
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| Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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| Product | SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System |
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| Code Information |
UDI/DI (01)00195278283481(11)231214(21)CNARC2300080TJ, System ID 82427110161;
UDI/DI (01)00195278283481(11)230519(21)CNARC2300027TJ, System ID 82427090471;
UDI/DI (01)00195278283481(11)231116(21)CNARC2300072TJ, System ID 82427120353;
UDI/DI (01)00195278283481(11)230830(21)CNARC2300051TJ, System ID 82427140303;
UDI/DI (01)00195278283481(11)230515(21)CNARC2300026TJ, System ID 82427200210;
UDI/DI (01)00195278283481(11)230809(21)CNARC2300046TJ, System ID 82427090487;
UDI/DI (01)00195278283481(11)230816(21)CNARC2300048TJ, System ID 82427010214;
UDI/DI (01)00195278283481(11)230719(21)CNARC2300040TJ, System ID 82427070331;
UDI/DI (01)00195278283481(11)230904(21)CNARC2300052TJ, System ID 82427090477;
UDI/DI (01)00195278283481(11)231102(21)CNARC2300068TJ, System ID 82427160409;
UDI/DI (01)00195278283481(11)230722(21)CNARC2300041TJ, System ID 82427040320;
UDI/DI (01)00195278283481(11)231120(21)CNARC2300073TJ, System ID 82427090470;
UDI/DI (01)00195278283481(11)231009(21)CNARC2300060TJ, System ID 82427030219;
UDI/DI (01)00195278283481(11)240104(21)CNARC2400002TJ, System ID 82427090488;
UDI/DI (01)00195278283481(11)231207(21)CNARC2300078TJ, System ID 82427090469;
UDI/DI (01)00195278283481(11)230918(21)CNARC2300056TJ, System ID 82427200214;
UDI/DI (01)00195278283481(11)240131(21)CNARC2400008TJ, System ID 82427030223;
UDI/DI (01)00195278283481(11)240113(21)CNARC2400005TJ, System ID 82427060120;
UDI/DI (01)00195278283481(11)231109(21)CNARC2300070TJ, System ID 82427130176;
UDI/DI (01)00195278283481(11)230920(21)CNARC2300057TJ, System ID 82427100480;
UDI/DI (01)00195278283481(11)231010(21)CNARC2300061TJ, System ID 82427100491;
UDI/DI (01)00195278283481(11)230729(21)CNARC2300043TJ, System ID 82427250136;
UDI/DI (01)00195278283481(11)240116(21)CNARC2400006TJ, System ID 82427250132;
UDI/DI (01)00195278283481(11)240110(21)CNARC2400004TJ, System ID 82427110160;
UDI/DI (01)00195278283481(11)231026(21)CNARC2300066TJ, System ID 82427100496;
UDI/DI (01)00195278283481(11)231204(21)CNARC2300077TJ, System ID 82427100504;
UDI/DI (01)00195278283481(11)230508(21)CNARC2300024TJ, System ID 82427160403;
UDI/DI (01)00195278283481(11)231221(21)CNARC2300081TJ, System ID 82427030207;
UDI/DI (01)00195278283481(11)240102(21)CNARC2400001TJ, System ID 82427120364;
UDI/DI (01)00195278283481(11)231019(21)CNARC2300064TJ, System ID 82427120360;
UDI/DI (01)00195278283481(11)240127(21)CNARC2400007TJ, System ID 82427200224;
UDI/DI (01)00195278283481(11)231030(21)CNARC2300067TJ, System ID 82427200207;
UDI/DI (01)00195278283481(11)231016(21)CNARC2300063TJ, System ID 82427140310;
UDI/DI (01)00195278283481(11)230818(21)CNARC2300049TJ, System ID 82427140317;
UDI/DI (01)00195278283481(11)230911(21)CNARC2300054TJ, System ID 82427140308;
UDI/DI (01)00195278283481(11)230913(21)CNARC2300055TJ, System ID 82427190195 |
Recalling Firm/
Manufacturer |
GE Medical Systems, LLC
3200 N Grandview Blvd
Waukesha WI 53188-1693
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| For Additional Information Contact | GE HealthCare Service
800-437-1171 |
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Manufacturer Reason
for Recall | Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. |
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FDA Determined
Cause 2 | Device Design |
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| Action | GE Healthcare issued an "URGENT MEDICAL DEVICE CORRECTION" notice to its consignees on 10/28/20224 delivered through a traceable means. The notice explained the issue, safety issue, and requested the following actions be taken for the continued safe usage of the affected devices:
"Ensure hearing protection with a Noise Reduction Rating (NRR) of at least 33dB is used during exams on these systems. 200 pairs are provided with this letter.
Please post this letter in your facility on or near the MR operator console.
Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions.
Please retain this document for your records."
Please complete and return the attached acknowledgement form to
recall.60998@gehealthcare.com.
For questions or concerns, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative. |
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| Quantity in Commerce | 3 units |
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| Distribution | Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = LNH
510(K)s with Product Code = LNH
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