Z-2325-2016 Class II Terminated
FDA device recall Z-2325-2016 was initiated by B-K Medical A/S on June 28, 2016 and is designated Class II. 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… The recall status is terminated (terminated August 29, 2016). Affected quantity: 6.
Recall Details
- Product Type
- Devices
- Report Date
- August 10, 2016
- Initiation Date
- June 28, 2016
- Termination Date
- August 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product Description
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
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.
Distribution Pattern
Worldwide Distribution - US to TX, FL, and MA. Internationally to Australia
Code Information
Serial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277