Reported Nov 12, 2025 · Ongoing
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus…
B-K Medical A/S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B-K Medical A/S · Mileparken 34 · Herlev, N/A · N/A
Is this the product you have?
1202 Flex Focus Ultrasound Systemcart models UA1214 and UA1814
- used with
Flex Focus 200Flex Focus 300Flex Focus 400Flex Focus 500Flex Focus 700Flex Focus 800SystemImagingPulsed DopplerUltrasonic
- Lot codes and dates
- 1) GTIN 05704916001056
- Serial Numbers
3,618 of 3,618 codes
400509040057104002577400180740022114004085400642440047724101695400642041008944003775400472440003214004803410175541017574004635400464140030824004188400444841002134101302400046640029824006605400494141007134003569400339040066084101728410190640054904100128400150240059224006602410172440059134101394400106640052304000771400153640034174004297410289341031044003275400457541003954004038400420140063504100035400612341000924005380
- Amount recalled
- 4426 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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