Recall Z-1091-2016
Verathon, Inc. · initiated November 30, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.
Codes / lots: SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA **************** A7001001, A7001002, A7001005, A7001007, A7001011, A7001022, A7001024, A7001031, A7001034, A7001036, A7001040, A7001041, A7001042, A7001043, A7001044, A7001045, A7001046, A7001047, A7001049, A7001050, A7001051, A7001052, A7001053, A7001054, A7001055, A7001056, A7001057, A7001060, A7001062, A7001065, A7001067, A7001068, A7001079, A7001080, A7001086, A7001088, A7001093, A7001094, A7001098, A7001101, A7001116, A7001117, A7001118, A7001119, A7001120, A7001121, A7001122, A7001123, A7001124, A7001125, A7001126, A7001127, A7001128, A7001129, A7001130, A7001131, A7001132, A7001138, A7001139, A7001140, A7001141, A7001143, A7001144, A7001146, A7001147, A7001148, A7001150, A7001151, A7001152, A7001153, A7001155, A7001156, A7001157, A7001158, A7001161, A7001162, A7001163, A7001164, A7001165, A7001168, A7001169, A7001170, A7001171, A7001172, A7001173, A7001174, A7001175, A7001176, A7001177, A7001178, A7001179, A7001180, A7001181, A7001182, A7001183, A7001184, A7001185, A7001186, A7001187, A7001188, A7001189, A7001190, A7001191, A7001192, A7001194, A7001195, A7001196, A7001197, A7001198, A7001199, A7001201, A7001202, A7001204…
Reason for recall
The firm is providing customers with an updated Operations and Maintenance Manual for each of the BladderScan BVI 9600 and AortaScan AMI 9700 devices. The updated Operations and Maintenance Manuals clarify that these devices should not be used for the screening, detection, or diagnosis of abdominal aortic aneurysms (AAAs).
FDA-determined cause: Device Design
Action taken
Verathon sent an URGENT: MEDICAL DEVICE CORRECTION BLADDERSCAN BVI 9600 WITH AORTASCAN MODE & AORTASCAN AMI 9700 letter dated November 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Verathon will manage other international consignees outside Europe internally and follow a similar approach as the firm requested Stericycle to perform. Verathon will instruct the companys foreign distributors to communicate the Customer Correction Letter and provide the revised OMMs to their international customers. This current Medical Device Correction is intended to reinforce the message in the May 2014 communication regarding the potential variance in measurement and to provide you with updated Operation and Maintenance Manuals that further reinforce the devices intended use and indications for use and that revise warning information, including warnings specified in the May 2014 communication. Customers are instructed to destroy all existing Operations and Maintenance Manuals and replace them with updated versions and complete the information on the Medical Device Correction Reply Form and fax or email the completed form within 10 business days to: Fax: (877) 907-9956 or Email: verathon3108@stericycle.com. Customers with any questions can contact your Verathon representative or Verathon Customer Care at (866) 875-0382. Verathon has live agent support on Monday through Friday from 8am to 5 pm Pacific Time. Customers should report any suspected malfunction or adverse event related to any AortaScan AMI 9700 devices and any BladderScan BVI 9600 devices to Verathon Customer Care at (800) 331-2313
Details
- Recall number
- Z-1091-2016
- Initiated
- November 30, 2015
- Terminated
- October 12, 2016
- Product code
- IYO – System, Imaging, Pulsed Echo, Ultrasonic
- Quantity
- 2524 units total (1441 units of BVI 9600 and 820 units of AMI 9700 in US; 209 units of BVI 9600 and 54 units of AMI 9700 OUTSIDE the US
- Distribution
- Worldwide Distribution - US (nationwide) and to the countries of : Guam, United Arab Emirates, Australia, Belgium, Canada , China, Czech Republic, France, Germany, Luxembourg, Netherlands, Norway, Saudi Arabia, Sweden , Taiwan, and United Kingdom
- Recalling firm
- Verathon, Inc., Bothell, WA