Reported Nov 12, 2025 · Ongoing
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
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?
- Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
- Lot codes and dates
- 1) 1300-21: GTIN 05704916001285 and pending
- Serial Numbers
1,481 of 1,481 codes
200269020084662008495200677450126835013881501268420087252008280200441950129802007101200902950143332003852200285120021422005860501393720071882002950200349520084705013934501393550162112005193501414150145145015892501210420090122009153501297620081852008137501230750141392000774200623720081445012319501490650127895015458200660220043792007123200824250113532007736501480320062355011354200204920052815015083501508720085275016292
- Serial Numbers
217 of 217 codes
200727420017542003771200361120058422007514200498620037732006652200607220053292006408200572820032392002206200608520054442002946200598720064535014797200676820068762007053501601920034532004206200419720013872006265200374650158972002715501620220036562002551200711550159162007564200102420043622004577200291120019222005628200585620028602003750200621220029452005670200234020076762004148200311620018225015641501600620071412005339
- Amount recalled
- 1697 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new B-K Medical A/S recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.