Food, drugs, devices › B-K Medical A/S
Device recall: 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 (Herlev, N/A) initiated this device recall on 9 Oct 2025; FDA lists 6 product records under event 97830, classified Class II.
FDA defines Class II as 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. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. B-K Medical A/S has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
B-K Medical A/S, Herlev, N/A, Denmark.
Reason for recall
"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."
Distribution
"Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0435-2026 | 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic | 4426 units | Class II | Ongoing | 12 Nov 2025 |
| Z-0436-2026 | Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic | 1697 units | Class II | Ongoing | 12 Nov 2025 |
| Z-0437-2026 | UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic | 567 units | Class II | Ongoing | 12 Nov 2025 |
| Z-0438-2026 | bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic | 496 units | Class II | Ongoing | 12 Nov 2025 |
| Z-0439-2026 | bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic | 124 units | Class II | Ongoing | 12 Nov 2025 |
| Z-0440-2026 | bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic | 895 units | Class II | Ongoing | 12 Nov 2025 |
Context
Other enforcement events for B-K Medical A/S
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Sep 2024 | bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound sy | Device | Class II | 1 |
| 30 Nov 2023 | bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66. | Device | Class II | 1 |
| 28 Jun 2016 | BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The sys | Device | Class II | 1 |
All 4 events for B-K Medical A/S
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.