Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Medical device recall Z-2097-2025. Published in FDA’s Enforcement Report on Jul 16, 2025.
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 Jul 16, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1822 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?
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
1822, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: Infinia I 16143 16149 16179 16315 16335 16353 16826 17339 17799 18420 18442 18604 18605 18611 18624 18627 18628 18629 18637 18639 18641 18644 18645 18647 18648 18649 18650 18651 18652 18653 18655 18656 18657 193S08002;…
Every code shown here, 1,995 characters
Serial Numbers: Infinia I 16143 16149 16179 16315 16335 16353 16826 17339 17799 18420 18442 18604 18605 18611 18624 18627 18628 18629 18637 18639 18641 18644 18645 18647 18648 18649 18650 18651 18652 18653 18655 18656 18657 193S08002; Infinia I Hawkeye 1 15006 15007 15013 16001 16003 16004 16005 16006 16007 16008 16009 16011 16012 16013 16015 16016 16019 16021 16022 16024 16026 16027 16028 16030 16033 16037 16038 16039 16043 16044 16048 16049 16050 16051 16052 16054 16057 16059 16060 16063 16064 16065 16070 16073 16074 16079 16081 16082 16083 16084 16087 16091 16099 16107 16109 16114 16123 16126 16127 16132 16134 16137 16140 16141 16148 16151 16153 16154 16155 16158 16159 16163 16164 16166 16168 16169 16171 16172 16173 16175 16177 16178 16182 16186 16433; Infinia II 16045 16094 16115 16135 16170 16190 16191 16194 16196 16198 16206 16207 16208 16209 16211 16212 16213 16214 16218 16220 16221 16223 16224 16227 16228 16229 16234 16235 16239 16244 16246 16250 16259 16262 16263 16271 16279 16285 16296 16303 16304 16305 16310 16312 16313 16318 16319 16322 16323 16324 16326 16334 16336 16355 16356 16365 16370 16371 16372 16376 16382 16404 16408 16411 16412 16413 16415 16418 16419 16421 16425 16426 16428 16434 16437 16442 16446 16455 16456 16457 16460 16465 16466 16469 16470 16474 16475 16478 16483 16489 16491 16497 16499 16500 16504 16509 16513 16525 16526 16528 16531 16533 16538 16539 16541 16542 16553 16557 16559 16560 16564 16566 16576 16579 16583 16585 16587 16592 16608 16611 16614 16621 16626 16627 16628 16632 16634 16635 16636 16639 16640 16643 16645 16646 16648 16649 16656 16657 16658 16659 16660 16661 16662 16663 16664 16665 16667 16668 16670 16672 16673 16677 16680 16683 16686 16692 16694 16695 16696 16699 16705 16706 16710 16712 16715 16716 16719 16720 16725 16732 16733 16734 16736 16738 16739 16743 16746 16748 16750 16751 16758 16760 16761 16766 16767 16768 16770 16772 16773 16775 16776 16779 16783 16786 16788 16789 16790 16792 16793 16794 16800 16802 16803…
FDA’s list runs to 11,117 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 - US Nationwide distribution.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Jun 20, 2025.
- FDA classified it on Jul 8, 2025.
- FDA’s Enforcement Report published it on Jul 16, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, of Tirat Carmel, Israel.
- 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 11,117 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
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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.