Z-2325-2016Class II

BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and...

Name: Z-2325-2016 BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and...
Creator: B-K Medical A/S
Published: 2016-06-28
License: https://open.fda.gov/license/

BK Medical ApS / initiated 2016-06-28 / Terminated / root cause: software

FDA source

B-K Medical A/S began a recall of BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic... on 2016-06-28. FDA classified it as Class II and gives the reason as "In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be unaware of the calculation factor (1) and assume the generic volume calculation factor is similar to that of the other...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2325-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-28
Posted: 2016-08-03
Terminated: 2016-08-29
Recalling firm: BK Medical ApS
Product: BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be unaware of the calculation factor (1) and assume the generic volume calculation factor is similar to that of the other (prostate, adenoma, testis, kidney, and bladder) volume calculation factors provided in the software.
Root cause tag: software
FDA root cause: Software design
Action: BK Medical sent an Important Corrective Action Notification letter dated June 27, 2016, to all affected customers. The letter explains the issue and asks customers to discontinue the use of the generic volume measurement and contact BK medical ApS Service for assistance. Customers with questions were instructed to call 800-645-4442.
Quantity in commerce: 6
Distribution: Worldwide Distribution - US to TX, FL, and MA. Internationally to Australia
Product codes and lots: Serial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2325-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2325-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-03

Product code IYN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)