GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a)
Medical device recall Z-0788-2019. Published in FDA’s Enforcement Report on Feb 6, 2019.
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 Feb 6, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 1,897 units 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?
Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when used in specific types of scans and with specific probes.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric). Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, vascular).
1,897 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: (a) Model BT09 130913SU7 127352SU3 130833SU7 130916SU0 125037SU2 116717SU0 130918SU6 131929SU2 127354SU9 126738SU4 106959SU0 114157SU1 115431SU9 115621SU5 106958SU2 116720SU4 121210SU9 130914SU5 130919SU4 132216SU3…
Every code shown here, 1,991 characters
Serial Numbers: (a) Model BT09 130913SU7 127352SU3 130833SU7 130916SU0 125037SU2 116717SU0 130918SU6 131929SU2 127354SU9 126738SU4 106959SU0 114157SU1 115431SU9 115621SU5 106958SU2 116720SU4 121210SU9 130914SU5 130919SU4 132216SU3 113312SU3 130241SU3 111546SU8 120810SU7 112875SU0 123137SU2 112879SU2 112095SU5 113765SU2 115170SU3 117847SU4 128516SU2 103781SU1 131404SU6 125738SU5 120806SU5 120808SU1 127924SU9 128512SU1 128830SU7 128827SU3 130243SU9 106949SU1 122763SU6 111035SU2 111034SU5 112405SU6 106953SU3 110077SU5 113766SU0 106951SU7 116713SU9 122758SU6 127351SU5 130242SU1 111549SU2 126600SU6 126739SU2 112799SU2 123139SU8 121513SU6 123136SU4 128513SU9 131407SU9 123138SU0 122115SU9 118304SU5 132214SU8 132371SU6 106962SU4 123141SU4 113310SU7 115626SU4 113313SU1 121212SU5 126126SU2 111548SU4 132372SU4 121209SU1 130917SU8 128826SU5 122426SU0 127923SU1 113767SU8 106952SU5 112876SU8 131926SU8 126542SU0 128828SU1 120807SU3 114158SU9 112878SU4 131930SU0 132217SU1 130837SU8 114636SU4 130915SU2 132370SU8 125741SU9 127347SU3 122117SU5 126740SU0 122422SU9 118303SU7 115432SU7 115433SU5 132218SU9 121211SU7 122756SU0 122761SU0 125033SU1 120809SU9 115623SU1 127348SU1 122430SU2 116715SU4 116714SU7 106957SU4 115624SU9 130836SU0 112880SU0 130835SU2 114159SU7 131408SU7 131405SU3 120803SU2 121511SU0 121509SU4 114637SU2 115622SU3 125739SU3 125736SU9 125740SU1 106960SU8 122118SU3 125038SU0 127925SU6 110529SU5 122424SU5 125036SU4 126543SU8 115171SU1 130834SU5 112877SU6 116719SU6 125035SU6 121510SU2 112094SU8 106945SU9 122759SU4 126128SU8 122423SU7 116711SU3 131098SU6 131097SU8 131095SU2 131094SU5 122970SU7 126955SU4 120371SU0 126321SU9 131875SU7 107577SU9 109713SU8 128321SU7 130282SU7 127191SU5 106008SU6 126319SU3 107573SU8 120307SU4 122000SU3 119052SU9 119051SU1 121753SU8 124984SU6 124997SU8 126953SU9 116922SU6 130294SU2 124979SU6 109840SU9 128917SU2 118015SU7 118016SU5 118017SU3 118005SU8 118006SU6 118008SU2 118007SU4 118000SU9 117999SU3 118010SU8 117996SU9 118028SU0 118027SU2…
FDA’s list runs to 18,139 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.
These words name no state.
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 28, 2018.
- FDA classified it on Jan 30, 2019.
- FDA’s Enforcement Report published it on Feb 6, 2019.
- FDA terminated it on Oct 5, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, 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 18,139 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.