| Class 2 Device Recall Verathon BladderScan BVI 9400 |  |
Date Initiated by Firm | May 18, 2009 |
Date Posted | September 17, 2009 |
Recall Status1 |
Terminated 3 on October 07, 2010 |
Recall Number | Z-1939-2009 |
Recall Event ID |
52769 |
510(K)Number | K071217 |
Product Classification |
Ultrasonic pulsed echo imaging system - Product Code IYO
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Product | The BladderScan BVI 9400 is a portable ultrasound instrument that provides a noninvasive measurement of urinary bladder volume. The device consists of an ultrasound probe that scans the patient's bladder, and a battery operated console that provides measurement related information. The BVI 9400 measures ultrasonic reflections on multiple planes inside the body and produces a three dimensional image. Based on the image, the BVI 9400 calculates and displays bladder volume. |
Code Information |
Units with serial numbers ranging from 1000 to 3179 are affected. (Serial number 1564 was not used.) The serial number is assigned as a sequential number, with no breakdown. |
Recalling Firm/ Manufacturer |
Verathon, Inc. 20001 N Creek Pkwy Bothell WA 98011-8218
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For Additional Information Contact | 800-331-2313 |
Manufacturer Reason for Recall | Three specific issues are being addressed:
1. Calculation and use of an incorrect year in dates after 12/31/2009.
2. Double scans, continuous scans, and double printing.
3. Calibration sensitivity. |
FDA Determined Cause 2 | Software design |
Action | U.S. customers (including Government) were sent a post card on or about 5/18/2009 and were called about the upgrade. Units are to be upgraded by the customers using an online tool called ScanPoint. Customers may elect to return their units to the firm for upgrading.
Canadian customers were phoned by Verathon.
For foreign units sold and distributed through one of the recalling firm's related firms, Service Bulletin SB-0014 was sent to the distributors located in The Netherlands, United Kingdom, and Australia.
Contact Verathon Customer Care at 1-800-331-2313 if you have any questions. |
Quantity in Commerce | 1,978 |
Distribution | Worldwide - US, Canada, Malaysia, Hong Kong, Singapore, Argentina, New Zealand, Barbados, Dominican Republic, and Costa Rica. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = IYO
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