[pending] Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Do
Pending LLM rewrite. Source: FDA_DEVICE Z-0436-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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 recalled product
- Product
- Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
- Manufacturer
- B-K Medical A/S
- Category
- Medical Device — Devices
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) 1300-21: GTIN 05704916001285 and pending
- Serial Numbers: 2002690
- 2008466
- 2008495
- 2006774
- 5012683
- 5013881
- 5012684
- 2008725
- 2008280
- 2004419
- 5012980
- 2007101
- 2009029
- 5014333
- 2003852
- 2002851
- 2002142
- 2005860
- 5013937
Distribution
Distributed nationwide across the United States.
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