The Recall Desk
HighFDA (Devices)·Z-1010-2022·Announced 2022-05-04

Acuson 9vE4 Ultrasound Transducers Recalled for Potential Thermal Injury Risk

Siemens is recalling 31 Acuson 9vE4 ultrasound transducers that may exceed thermal index limits, creating a potential risk of thermal injury. Affected units were distributed in US states and international locations.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall where no illnesses or injuries have been reported. The hazard represents a theoretical risk of thermal injury from transducers exceeding recommended thermal index limits. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling Acuson 9vE4 Transducers (Model 240/11289564, CE0129). These ultrasound transducers may exceed FDA-recommended thermal index limits during operation. The thermal index is a measurement used to estimate potential tissue heating from ultrasound energy; exceeding these limits creates a potential risk of thermal injury to patients or operators.

The recall affects 31 units distributed in the United States (Washington, Alaska, Ohio, South Carolina, Pennsylvania, Arizona, New York, and Texas) and internationally (Australia, Czech Republic, France, United Kingdom, Indonesia, Mexico, and New Zealand). Affected serial numbers are: 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.

Healthcare facilities and providers using affected transducers should verify their device serial numbers against the FDA recall notice. If an affected unit is identified, contact Siemens Medical Solutions USA, Inc. for further guidance on remediation or replacement. The UDI/DI for this device is (01)4056869243566.

The recalled product

Product
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Manufacturer
Siemens Medical Solutions USA, Inc.
Category
Medical Device — Ultrasound Equipment
Hazard
  • thermal-injury
  • thermal-index-excess

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI/DI - (01)4056869243566

Distribution

Distributed nationwide across the United States.

Related recalls

Same category