B105P, B125P, B105M, B125M, B155M Patient Monitors
Medical device recall Z-0455-2026. 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
- 7408 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?
B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101 6160000-102 6160000-103 6160000-104 6160000-105 6160001-063 6160001-064 6160001-065 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms 3/19/26 updated to add B105P Patient Monitor 6160001-061 B125P Patient Monitor 6160001-062 B105M-C Patient Monitor 6160002-033 B105M-A Patient Monitor 6160000-113 B155M-A Patient Monitor 6160000-115 B125P-B Patient Monitor 6160002-022 B105M-B Patient Monitor 6160002-023 B125M-B Patient Monitor 6160002-024 B105M-OR Patient Monitor 6160000-143 B105M-OR Patient Monitor 6160000-144 B155M-OR Patient Monitor 6160000-145
7408, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model No. 6160000-002 UDI-DI 00840682147224 Serial Nos. SR525270031WA SR525270032WA SR525270033WA SR525270034WA SR525270035WA SR525270036WA SR525270037WA SR525270038WA SR525270039WA SR525270040WA SR525270041WA SR525270042WA SR525270043WA…
Every code shown here, 1,990 characters
Model No. 6160000-002 UDI-DI 00840682147224 Serial Nos. SR525270031WA SR525270032WA SR525270033WA SR525270034WA SR525270035WA SR525270036WA SR525270037WA SR525270038WA SR525270039WA SR525270040WA SR525270041WA SR525270042WA SR525270043WA SR525270044WA SR525270045WA SR525270046WA SR525270047WA SR525270048WA SR525270049WA SR525270050WA SR525270051WA SR525270052WA SR525270053WA SR525270054WA SR525270055WA SR525270056WA SR525270057WA SR525270058WA SR525270059WA SR525270060WA ; Model No. 6160000-003 UDI-DI 00840682146708 Serial Nos. SR625210256SA SR625200211SA SR625200212SA SR625200213SA SR625200214SA SR625200215SA SR625300322SA SR625170208SA SR625220268SA SR625130040SA SR625130041SA SR625130042SA SR625130043SA SR625130024SA SR625130025SA SR625130026SA SR625130027SA SR625130028SA SR625130029SA SR625130030SA SR625130031SA SR625130032SA SR625130033SA SR625130034SA SR625130035SA SR625170158SA SR625170159SA SR625240284SA SR625210265SA SR625210266SA SR625110137SA SR625060181SA SR625060182SA SR625060183SA SR625060184SA SR625060185SA SR625060186SA SR625060187SA SR625060188SA SR625060189SA SR625060190SA SR625170160SA SR625170161SA SR625170162SA SR625170163SA SR625170164SA SR625170165SA SR625170166SA SR625170167SA SR625170168SA SR625170169SA SR625170170SA SR625170156SA SR625070053SA SR625070054SA SR625070055SA SR625070056SA SR625070057SA SR625070058SA SR625070059SA SR625070060SA SR625070061SA SR625070062SA SR625070063SA SR625070064SA SR625070065SA SR625170146SA SR625170147SA SR625170148SA SR625170149SA SR625170150SA SR625170151SA SR625170199SA SR625170200SA SR625170201SA SR625170202SA SR625170203SA SR625170204SA SR625170205SA SR625170206SA SR625060001SA SR625060002SA SR625060003SA SR625060004SA SR625060005SA SR625060006SA SR625060007SA SR625060008SA SR625060009SA SR625060010SA SR625060011SA SR625060012SA SR625060013SA SR625060014SA SR625060015SA SR625060016SA SR625060017SA SR625060018SA SR625060019SA SR625060020SA SR625060021SA SR625060022SA SR625060023SA SR625060024SA…
FDA’s list runs to 105,069 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 105,069 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.