| | 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-0518-2025 |
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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
|
| Product | SIGNA Architect, Nuclear Magnetic Resonance Imaging System |
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| Code Information |
UDI/DI (01)00840682147095(11)240100(21)PG75M2400278SC, System ID 303467MR2;
UDI/DI To be provided, System ID 1000005000;
UDI/DI (01)00840682147095(11)220800(21)PG75M2300225SC, System ID 217528MR4;
UDI/DI (01)00840682147095(11)220600(21)PG75M2200130SC, System ID 781SSHMR3;
UDI/DI To be provided, System ID 301295AMR2;
UDI/DI To be provided, System ID GON90303794;
UDI/DI To be provided, System ID 215955HON3T;
UDI/DI (01)00840682147095(11)230600(21)PG75M2300245SC, System ID 806UMCHWMR3T;
UDI/DI (01)00840682147095(11)230800(21)PG75M2300255SC, System ID 703573ARC7;
UDI/DI (01)00840682122702(11)220100(21)PG75A2300133SC, System ID 757953SPMR;
UDI/DI (01)00840682147095(11)231000(21)PG75M2300263SC, System ID 905684MR3T;
UDI/DI (01)00840682147095(11)220800(21)PG75M2200153SC, System ID 82427160355;
UDI/DI To be provided, System ID 82427100482;
UDI/DI To be provided, System ID 82427140330;
UDI/DI To be provided, System ID 82427040333;
UDI/DI To be provided, System ID 82427200209;
UDI/DI To be provided, System ID 82427050061;
UDI/DI To be provided, System ID 82427080138;
UDI/DI (01)00840682147095(11)230400(21)PG75M2300232SC, System ID 82427150128;
UDI/DI To be provided, System ID 82427200219;
UDI/DI To be provided, System ID 82427080142;
UDI/DI To be provided, System ID 82427230234;
UDI/DI (01)00840682147095(11)231000(21)PG75M2300266SC, System ID 82427100499;
UDI/DI To be provided, System ID 82427160405;
UDI/DI To be provided, System ID 82427160407;
UDI/DI (01)00840682147095(11)230600(21)PG75M2300247SC, System ID 82427160390;
UDI/DI To be provided, System ID 82427160408;
UDI/DI To be provided, System ID 82427160402;
UDI/DI To be provided, System ID 82427120372;
UDI/DI To be provided, System ID 82427120357;
UDI/DI To be provided, System ID 82427120351;
UDI/DI (01)00840682147095(11)230700(21)PG75M2300253SC, System ID 82427150130;
UDI/DI (01)00840682147095(11)240100(21)PG75M2400276SC, System ID 82427030222;
UDI/DI (01)00195278283481(11)231113(21)CNARC2300071TJ, System ID 82427030218;
UDI/DI (01)00840682147095(11)230600(21)PG75M2300248SC, System ID 83027009451123;
UDI/DI (01)00840682147095(11)240200(21)ANTAT2400005TJ, System ID MR00169;
UDI/DI (01)00840682147095(11)240200(21)ANTAT2400004TJ, System ID MR00168;
UDI/DI (01)00840682147095(11)240100(21)ANTAT2400001TJ, System ID MR00185;
UDI/DI (01)00840682122702(11)180223(21)PG75A1800019MR, System ID 850270540;
UDI/DI To be provided, System ID 850270791;
UDI/DI To be provided, System ID LV4001MR03;
UDI/DI (01)00840682147095(11)230600(21)PG75M2300246SC, System ID MRUA2408;
UDI/DI To be provided, System ID P00434MR01;
UDI/DI To be provided, System ID RF3138MR01;
UDI/DI To be provided, System ID RU1838MR04;
UDI/DI To be provided, System ID RF3580MR01;
UDI/DI To be provided, System ID SA1058MR05;
UDI/DI (01)00840682147095(11)221100(21)PG75M2200180SC, System ID FEG88320;
UDI/DI (01)00840682147095(11)230800(21)PG75M2300256SC, System ID DE492A99;
UDI/DI To be provided, System ID NEV439249;
UDI/DI To be provided, System ID 853270212;
UDI/DI To be provided, System ID 853270202;
UDI/DI (01)00840682147095(11)230300(21)PG75M2300227SC, System ID 853270223 |
Recalling Firm/
Manufacturer |
GE Medical Systems, LLC
3200 N Grandview Blvd
Waukesha WI 53188-1693
|
| 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 | 53 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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