Recall Z-1010-2022 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
| Date | Apr 27, 2022 (initiated Mar 7, 2022) |
| Status | Open, Classified |
| Reason | Transducers (component of ultrasound system) may exceed recommended thermal index limits |
| Root cause | Process control |
| Action | On 4/1/22, Siemens issued a "Urgent Medical Device Safety Correction" via: email to affected consignees. Prior to receiving the email the firm's representatives contacted consignees by phone or by visit to inform them of the recall. In addition, to providing consignees with information on the recalled product, Siemens asked consignees to take the following actions: Immediately stop performing procedures using the ACUSON 9VE4 transducer and segregate the product. Please ensure that all users of the affected transducer within your organization, and others who may need to be informed, receive |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211859 | ACUSON Sequoia Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc., Jul 20, 2021 |