AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
Medical device recall Z-0068-2026. Published in FDA’s Enforcement Report on Oct 15, 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 Oct 15, 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
- 7,302 (1,381 US; 5,921 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?
Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
7,302 (1,381 US; 5,921 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI 00840682102384 System IDs 907729AWS1 720238AW1 907ULMCCT 205934AWSRV 205975AWSRV 205971AWS 205510VAW 205815AWS2 UABMAWS1 749153GE3 UABMRPET 256593AW1 256265AWS4 256265AWS3 205481AWS1 251343AWS 251665MCIAWS 251316VAWS 251435AW5…
Every code shown here, 1,990 characters
UDI-DI 00840682102384 System IDs 907729AWS1 720238AW1 907ULMCCT 205934AWSRV 205975AWSRV 205971AWS 205510VAW 205815AWS2 UABMAWS1 749153GE3 UABMRPET 256593AW1 256265AWS4 256265AWS3 205481AWS1 251343AWS 251665MCIAWS 251316VAWS 251435AW5 251435AWSMARTSUB1 303584HP To be provided 251435AWSSMARTSUB1 256386AW1 205RCAWS 870423AWSMARTSUB1 870642AWS 718329SMART11 479314AWS1 479314AWS2 870207AW1 501686AWS31 501978AW1 501686AWSMARTSUB2 501552AW2 501202AWS1 501686AWSMARTSUB1 479338AWS 928773AWS 928214AWS 480256AWS 928757AWEN To be provided pacsaws01 To be provided 602344AWS 602651AWS 480342AWS 602277REVAW 480342AWSMARTSUB2 480342AWSMART1 480342AWSMART2 602344AWS1 602344SMARTAW 480342AWS2 602BUMC870 480342AWSMARTSUB3 928445AW1 06A6A668-AW-AWS_PRIMARY 844823AW1 844823AW 928283AWSMARTSUB1 520STJAWS 818RIAWSVR 661CHAWS 661KMCAWS 13123 13767 650696AWS To be provided 530UCVETAWSERV To be provided 760633HDCT To be provided 714FVAWSERVER 714FVDISC 510792AWH 559326AWS1 714447AWS AVHHFCTAW1 858657AWSMARTSUB2 858626AWS32 858824AWSMARTSUB2 858824SMARTSUB1 To be provided 909558SMART 805737AW2 562826AW46 9694 9693 323361AWSMARTSUB1 13256B To be provided 13526B 559353AW1 949367AWS 323BEVAWS 951704AWS 949764AWS 949764SMARTAW 510534AWS 510869AWSERV 510752AWS 916SUTABAWS 510437AWDL360 5496962AW11 510869APEX 760940AWS32 760940APEX 714771AWSRV 714456AWSMART 714456AW 650725AWS10 650725AWS30 650725AWSVM1 650725AWSVM2 650725AWSVM3 808341AW2 760446AWS 949278AW2 916SUTAWS 916SUTAWS2 916UCDAWS To be provided 858966SERVER 619532SERVER 9907 858657AWS32 858939EHLAWS 858626EHLAWS 858805AWSVM01 415600AWSERVER 415833AWSF 415476AWV 415MBCREV1 UCSFAWS4 UCSFAWS3 650725AWS20 408GSHOGEAW 408259EDCT 510784AWSERVER 9200 13195B 13196B 650696PET 805AWVM 310264AWS SHCGEAWSVM2 To be provided 818881AWSVR 805434AWS AWSHT1 310222HPAW 310823EHL1 310423EHL2 310423EHL1 To be provided 818782AWS1 To be provided 818676AW4 310423AWS 310423AWS2 To be provided 970544AWS 720848AWSRV 719365AWS DHAWSERV1 MCAAWSERV 303602AWS1…
FDA’s list runs to 81,465 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.
Domestic US distribution nationwide. International distribution worldwide.
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 Sep 5, 2025.
- FDA classified it on Oct 8, 2025.
- FDA’s Enforcement Report published it on Oct 15, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Medical Systems, SCS, of Buc, France.
- 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 81,465 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.