Acuson 9vE4 Transducer recall
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Why was Acuson 9vE4 Transducer recalled?
Transducers (component of ultrasound system) may exceed recommended thermal index limits
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI - (01)4056869243566; Affected Serial Numbers: BT10672 BT10582 BT10617 BT10643 BT10669 BT10580 BT10619 BT10659 BT10611 BT10612 BT10614 BT10673 BT10581 BT10494 BT10610 BT10641 BT10497 BT10615 BT10661 BT10667 BT00248 BT10613 BT10657 BT10640 BT10584 BT10488 BT10481 BT10644
- Product
- Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 31 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of Washington, Alaska, Ohio, South Carolina, Pennsylvania, Arizona, New York, Texas and the countries of Australia, Czech Republic, France, United Kingdom, Indonesia, Mexico, New Zealand.
- Recall date
- May 4, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)