Recall Z-0531-2021 ยท ITX Transducer, Ultrasonic, Diagnostic
Verathon, Inc.
BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
| Date | Sep 29, 2020 |
| Status | Terminated |
| Reason | Due to a change in handle material and process, probe handle may crack. |
| Root cause | Vendor change control |
| Action | On 10/5/2020, the firm sent a "Field Defect Correction URGENT MEDICAL DEVICE RECALL" Notification to its U.S, Customers via FedEx informing them that due to an unauthorized manufacturing change, the probe handle's plastic may become brittle and crack. Customer are instructed to: 1. Review the information contained within this Recall Notice with all staff members who should be aware of the contents of the letter. 2. Check the list of Serial Numbers that are provided within the Recall Response Form. 3. Perform a visual inspection of the probe handle for cracks or damage. 4. Based on the visua |
| Quantity | 398 units |
| Distribution | Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WI, WV and WY. The countries of Austrailia, Belgium, Canada, France, Germany, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172356 | BladderScan Prime PLUS System Verathon Incorporated, Sep 15, 2017 |