GE 1.5T and 3.0T Signa HDx MR System The product is used… recallZ-1890-2008 · GE Healthcare · initiated Dec 14, 2007
Terminated All recalls posted in September 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
GE healthcare has become aware of an artifact which could affect the diagnostic capability associated with the 3.0T Propeller T2 Flair application of the 3.0T Signa HDx scanner.
FDA root cause category: Software design
What the company is doing
Consignees were sent a "GE Healthcare Product Safety Notification" letter dated 9/14/07. The letter was addressed to Hospital Administrators, Managers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the safety issue, affected product, safety instructions, product correction and contact information. FMI 60745 and 60746 was communicated directly to the GE Healthcare service engineers who provide the modification at the customer site. For assistance, contact GE Healthcare at 1-262-544-3894.
Recall details
- Recall number
- Z-1890-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 14, 2007
- Posted by the FDA
- Sep 17, 2008
- Recalling firm
- GE Healthcare
- Quantity
- 122
- Product code
- LNH
- FDA submissions
- K052293
- Distribution
- AL, CA, CO,CT, AZ, FL, GA, LA, MS, MT, IA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NY, NV, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PUERTO RICO. AUSTRALIA, CHINA, HONG KONG, INDIA, JAPAN, SOUTH KOREA, NEW ZEALAND, TAIWAN, SWITZERLAND, GERMANY, DENMARK, SPAIN, FRANCE, GREAT BRITAIN, IRELAND, IRAN, ITALY, KUWAIT, LEBANON, NETHERLANDS, NORWAY, RUSSIA, SAUDI ARABIA, TURKEY, SOUTH AFRICA, BRAZIL, CANADA, and MEXICO.
Product description
GE 1.5T and 3.0T Signa HDx MR System The product is used as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the body.
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
Model 5127452: 00000HDMR20228 00000276057MR7 00000275160MR0 000000HDMR2544 00000HDMR10417 00000HDMR10094 00000274383MR9 00000273832MR6 00000274385MR4 00000276073MR4 00000274359MR9 00000HDMR10273 00000273119MR8 00000DDDM10670 00000HDMR20073 00000HDMR10739 000000HDMR2451 000000HDMR2335 00000HDMR20189 000000HDMR1004 00000HDMR10489 00000HDMR10291 00000HDMR20151 00000HDMR20061 00000HDMR10743 000000HDMR2528 000000HDMR2976 00000HDMR20044 000000HDMR2773 00000HDMR20294 00000HDMR20059 00000HDMR10418 00000HDMR10831 00000HDMR20036 and 00000HDMR20056 Model 2377062-61 00000008376YR6 00000007126YR6 00000007551YR5 00000007555YR6 00000006690YR2 00000007518YR4 00000008525YR8 00000005222YR5 00000007134YR0 00000008354YR3 00000005989YR9 00000007107YR6 00000008100YR0 00000007594YR5 00000006710YR8 00000008103YR4 00000007092YR0 00000007503YR6 00000007574YR7 00000006754YR6 00000007542YR4 00000008116YR6 00000008522YR5 00000006685YR2 00000007105YR0 00000008564YR7 00000005974YR1 00000005545YR9 00000006705YR8 00000006600YR1 00000007585YR3 00000005532YR7 00000008549YR8 00000007533YR3 00000007498YR9 00000005231YR6 00000006583YR9 00000005216YR7 00000007554YR9 00000009031YR6 00000006708YR2 00000007117YR5 00000007864YR2 00000007866YR7 00000007514YR3 00000008342YR8 00000005546YR7 00000007892YR3 00000007865YR9 00000006556YR5 00000006660YR5 00000007862YR6 00000009421YR9 00000007556YR4 00000008378YR2 00000008539YR9 00000006656YR3 00000005536YR8 00000008115YR8 00000008335YR2 00000052299YR0 00000006727YR2 00000006726YR4 and 00000007572YR1 Model 2395001-2 00000280673MR5 00000278397MR5 00000277211MR9 00000276434MR8 00000275968MR6 00000278549MR1 00000280781MR6 00000276265MR6 00000275046MR1 00000283745MR8 00000284233MR4 00000275648MR4 00000280000MR1 00000279068MR1 00000275967MR8 00000274744MR2 00000276266MR4 00000280001MR9 00000278851MR1 00000275647MR6 00000281340MR0 00000275465MR3 and 00000282549MR5
Other devices under the same FDA submission
1 device cleared under K052293 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 1.5T SPLIT HEAD COILGE Medical Systems, L.L.C. · System, nuclear magnetic resonance imaging1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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