Lightspeed 16 CT
Medical device recall Z-2801-2015. Published in FDA’s Enforcement Report on Sep 30, 2015.
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 Sep 30, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 416 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?
Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Lightspeed 16 CT
416, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
00000058433HM4 4860LS16GS FMI25463004 910213080 FMI25463005 910212101 FMI25463006 910212105 FMI25463007 910213064 FMI25463008 910216041 FMI25463009 910216036 00000321402CN0 910212106 00000325191CN5 AH5362CT02 FMI25463010 190020CT03…
Every code shown here, 1,987 characters
00000058433HM4 4860LS16GS FMI25463004 910213080 FMI25463005 910212101 FMI25463006 910212105 FMI25463007 910213064 FMI25463008 910216041 FMI25463009 910216036 00000321402CN0 910212106 00000325191CN5 AH5362CT02 FMI25463010 190020CT03 FMI25463011 110807CT01 00000980106YM9 110040CT03 00000307018CN2 416249LS16 00000298660CN2 204787LSPD2 00000318927CN1 514468BLS 00000329994CN8 819561LS 00000389961CN4 709891CT 00000335314CN1 514934CLS16 00000340630CN3 82421140148 00000331165CN1 82421010103 00000336002CN1 82421130067 00000334898CN4 82421140150 00000322331CN0 82421160145 00000999187YM8 82421100291 FMI25463133 828210047 FMI25463136 82421310073 00000989604YM4 82421030247 FMI25463015 82421010063 00000075153HM7 82421120171 FMI25463016 082421ATCLSP04 FMI25463017 82421100443 00000080677HM8 82421090111 00000092789HM7 82421120191 00000092771HM5 82421120188 00000074379HM9 82421060038 FMI25463018 82421130055 00000092530HM5 82421110048 00000080298HM3 82421100270 FMI25463019 395291CT01 FMI25463020 PM1633CT04 FMI25463021 PC7479CT02 FMI25463022 DK1025CT02 00000420281CN8 NP384114 FMI25463023 FI2000MN01 00000953833YM1 FI1052CT02 FMI25463024 C6010809 FMI25463025 M1076839 FMI25463026 M40345153 FMI25463027 M4496936 FMI25463028 M4409416 FMI25463029 M2147233 FMI25463030 M4505261 FMI25463031 M4020535 FMI25463032 M4491526 FMI25463033 M2802781 FMI25463034 X971285001 FMI25463035 A4463317 FMI25463036 B4195716 00000320672CN9 M4160064 00000271501CN9 M4182817 00000302750CN5 HC3314CT02 00000311056CN6 PC1268CT03 00000980113YM5 PROS01CT04 00000309302CN8 HC3428CT02 00001033124YM7 HC1560CT05 00000031399CN5 CC0618CT03 00000301205CN1 HC1627CT04 00000000716YC1 PX2261CT02 FMI25463041 GOLD010271 FMI25463042 GOLD010160 00000297465CN7 HU1039CT03 00000313648CN8 HU1008CT02 FMI25463043 835210046 FMI25463045 83021842100841 00000475152YM5 83097598280000 FMI25463046 83021002101343 FMI25463047 83021002101503 FMI25463048 83037594099999 00000342119CN5 83021042101703 00000319062CN6 83021200019012 00000326255CN7…
FDA’s list runs to 10,131 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 (nationwide) and to the countries of : ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGRY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, MEXICO, NORWAY, POLAND, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN and UNITED KINGDOM.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Jul 17, 2015.
- FDA classified it on Sep 21, 2015.
- FDA’s Enforcement Report published it on Sep 30, 2015.
- FDA terminated it on Mar 8, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
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 10,131 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.