Portrait VSM
Medical device recall Z-0456-2026. Published in FDA’s Enforcement Report on Nov 19, 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 Nov 19, 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
- 5990 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 loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms
5990, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI 00195278561312 Serial Nos. SWP25300030SA SWP25300031SA SWP25130712SA SWP25130713SA SWP25130714SA SWP25130715SA SWP25130716SA SWP25130717SA SWP25130718SA SWP25130719SA SWP25130720SA SWP25130721SA SWP25130722SA SWP25130723SA…
Every code shown here, 1,994 characters
UDI-DI 00195278561312 Serial Nos. SWP25300030SA SWP25300031SA SWP25130712SA SWP25130713SA SWP25130714SA SWP25130715SA SWP25130716SA SWP25130717SA SWP25130718SA SWP25130719SA SWP25130720SA SWP25130721SA SWP25130722SA SWP25130723SA SWP25130724SA SWP25130725SA SWP25130726SA SWP25130727SA SWP25130728SA SWP25130729SA SWP25130730SA SWP25130731SA SWP25130732SA SWP25130733SA SWP25130734SA SWP25130735SA SWP25130736SA SWP25130737SA SWP25130738SA SWP25130739SA SWP25130740SA SWP25130741SA SWP25230019SA SWP25230020SA SWP25230021SA SWP25230022SA SWP25230026SA SWP25210083SA SWP25210084SA SWP25130751SA SWP25130752SA SWP25130753SA SWP25170019SA SWP25170020SA SWP25170021SA SWP25170022SA SWP25170023SA SWP25170024SA SWP25200033SA SWP25200034SA SWP25200035SA SWP25160027SA SWP25180121SA SWP25180122SA SWP25180123SA SWP25230034SA SWP25230035SA SWP25230036SA SWP25250032SA SWP25250033SA SWP25290061SA SWP25260114SA SWP25260115SA SWP25260116SA SWP25260117SA SWP25250046SA SWP25250047SA SWP25250048SA SWP25250050SA SWP25240013SA SWP25120633SA SWP25130746SA SWP25170056SA SWP25250034SA SWP25290065SA SWP25051286SA SWP25110533SA SWP25190088SA SWP25210044SA SWP25260155SA SWP25260156SA SWP25260157SA SWP25260158SA SWP25120623SA SWP25120627SA SWP25130766SA SWP25130843SA SWP25130844SA SWP25151063SA SWP25151071SA SWP25151087SA SWP25170027SA SWP25170028SA SWP25290048SA SWP25290053SA SWP25110399SA SWP25151065SA SWP25180130SA SWP25260120SA SWP25151070SA SWP25180126SA SWP25180127SA SWP25220010SA SWP25300001SA SWP25300002SA SWP25300003SA SWP25300004SA SWP25300005SA SWP25300006SA SWP25300007SA SWP25300008SA SWP25210078SA SWP25220050SA SWP25190090SA SWP25190091SA SWP25190092SA SWP25220063SA SWP25120626SA SWP25210082SA SWP25110389SA SWP25110390SA SWP25120616SA SWP25120617SA SWP25130744SA SWP25130745SA SWP25160028SA SWP25180128SA SWP25220023SA SWP25220024SA SWP25220025SA SWP25220026SA SWP25220027SA SWP25220028SA SWP25220029SA SWP25220030SA SWP25220031SA SWP25220032SA SWP25220034SA SWP25220035SA SWP25220036SA…
FDA’s list runs to 83,966 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 Sep 26, 2025.
- FDA classified it on Nov 7, 2025.
- FDA’s Enforcement Report published it on Nov 19, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare Finland Oy, of Helsinki, Finland.
- 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 83,966 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.