GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS
Medical device recall Z-0553-2016. Published in FDA’s Enforcement Report on Oct 31, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 31, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 26 states named in where it went
- 90 (54 US; 36 OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.
90 (54 US; 36 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # System ID 00000001140049 BMDACCMR1 00000001140050 BMDACCMR1 0000011-4-0050 BMDACCMR1 0000011-4-0009 920568MR3T 0000011-4-0015 920568MR3T 0000011-4-0017 602406IMR 0000011-4-0018 602406IMR 0000011-4-0024 602406IMR…
Every code shown here, 1,987 characters
Mfg Lot or Serial # System ID 00000001140049 BMDACCMR1 00000001140050 BMDACCMR1 0000011-4-0050 BMDACCMR1 0000011-4-0009 920568MR3T 0000011-4-0015 920568MR3T 0000011-4-0017 602406IMR 0000011-4-0018 602406IMR 0000011-4-0024 602406IMR 0000014-4-0007 602406IMR 0000011-4-0028 626359MR3 0000011-4-0032 626359MR3 0000011-4-0046 MSK68MR4 0000011-4-0047 MSK68MR4 0000028-3-0011 MSK68MR4 0000044-4-0046 MSK68MR4 0000011-4-0064 415CB3TW 0000011-4-0065 415CB3TW 0000011-4-0066 415723SHAW12 0000011-4-0067 415723SHAW12 0000011-4-0075 616267IMRI 0000011-4-0076 616267IMRI 011-4-0085 616267IMRI 011-4-0170 616267IMRI 0000011-4-0094 330344MR750W 011-4-0118 330344MR750W 0000011-4-0101 713792CMR1 0000011-4-0102 713792CMR1 0000011-4-0107 317887MR3 0000011-4-0108 317887MR3 0000011-4-0114 309655MR750W 0000011-4-0115 309655MR750W 011-4-0117 517353DVMR 011-4-0172 517353DVMR 011-4-0119 614293MR9 011-4-0120 614293MR9 011-4-0124 MR229050 077-4-0123 MR229050 011-4-0125 6053223TMR 011-4-0126 6053223TMR 011-4-0129 6053223TMR 011-4-0130 6053223TMR 011-4-0146 480342MR3 011-4-0149 480342MR3 011-4-0154 773665SJMR2 011-4-0155 773665SJMR2 011-4-0162 720848MR4 011-4-0164 720848MR4 0000011-4-0055 415723SCHMR2 0000011-4-0062 405271OUCMR 0000011-4-0080 847872ZMR2 0000011-4-0106 949760MR3 011-4-0169 415UCBHMR3 MISSING_SN_GON4217108 408358SHMR13 Missing_SN_GON4227287 309655IMRI 0000011-4-0019 416369MR3T 0000011-4-0020 416369MR3T 011-4-0128 E416249MR2 11-4-0127 E416249MR2 0000011-4-0027 082427040101 0000011-4-0033 082427040101 0000011-4-0133 082427040167 0000011-4-0134 082427040167 0000011-4-0086 CS1006MR03 0000011-4-0092 CS1006MR03 0000011-4-0153 CS1006MR03 0000011-4-0158 A5547422 0000011-4-0159 A5547422 0000011-4-0103 EM0229 0000011-4-0104 EM0229 0000011-4-0156 EM0276 0000011-4-0157 EM0276 0000011-4-0165 EM0276 0000011-4-0166 EM0276 0000028-4-0016 RTD0191 0000011-4-0060 RTD0191 0000011-4-0061 RTD0191 0000011-4-0093 0920279024 0000011-4-0098 0920279024 0000011-4-0034 PER08626 0000011-4-0035 PER08626…
FDA’s list runs to 2,246 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution- US Distribution including the states of AZ, CA, CO, IL IN, MI, MN, NY, OH, OK, SD, TX, WI, VA, DE, FL, MD, ME, MO, NC, NH, OR, PA, TN, WI, DC, PR and the countries of CANADA, CHINA, CZECH REPUBLIC, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, PORTUGAL, ROMANIA, SOUTH AFRICA, SWITZERLAND, TURKEY, SWEDEN, AUSTRALIA, BRAZIL, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, ITALY, MEXICO, RUSSIA, SAUDI ARABIA, TAIWAN, UNITED KINGDOM, INDONESIA, ESTONIA, REPUBLIC OF KOREA, POLAND, KUWAIT, SPAIN.
The states and territories these words name
26 states and territories.
Every one of them
- Arizona
- California
- Colorado
- District of Columbia
- Delaware
- Florida
- Illinois
- Indiana
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- North Carolina
- New Hampshire
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- South Dakota
- Tennessee
- Texas
- Virginia
- Wisconsin
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 7, 2015.
- FDA classified it on Oct 22, 2018.
- FDA’s Enforcement Report published it on Oct 31, 2018.
- FDA terminated it on Nov 8, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Medical Systems, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Telephone.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,246 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.