The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0435-2026·Announced 2025-11-12

Flex Focus ultrasound carts recalled over incomplete battery safety instructions

B-K Medical is recalling 4,426 1202 Flex Focus ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 as a labeling deficiency: the record cites missing instructions rather than a device defect, and states no consequence or reported harm.

Plain-English summary

The 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with Flex Focus 200, 300, 400, 500, 700 and 800 systems, is being 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.

The recall covers 4,426 units, including GTIN 05704916001056, distributed worldwide including nationwide in the United States and to countries including Algeria, Argentina, Australia and Austria. The FDA has classified the action as Class II.

The enforcement record describes the documentation gap without stating a health consequence, and reports no injuries. Sites operating an affected system should follow the firm's instructions.

The recalled product

Product
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
Manufacturer
B-K Medical A/S
Category
Medical Device — Ultrasound system
Hazard
Affected units
4,426

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1) GTIN 05704916001056
  • Serial Numbers: 4005090
  • 4005710
  • 4002577
  • 4001807
  • 4002211
  • 4004085
  • 4006424
  • 4004772
  • 4101695
  • 4006420
  • 4100894
  • 4003775
  • 4004724
  • 4000321
  • 4004803
  • 4101755
  • 4101757
  • 4004635
  • 4004641

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by B-K Medical A/S under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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