Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Summary
The FDA issued a Class II for Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only , by Siemens Medical Solutions USA, Inc.. Reason: Transducers (component of ultrasound system) may exceed recommended thermal index limits.
Details
Source
Device Recall
External ID
Z-1010-2022
Action Date
2022-05-04
Status
Ongoing
Category
device
Product Description
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Lot/Code Info: 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
Quantity Affected: 31 units
Reason for Recall
Transducers (component of ultrasound system) may exceed recommended thermal index limits
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-07
Company
Issaquah, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 155 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Siemens Medical Solutions USA, Inc. has 277 FDA actions in our database, including 173 recalls and 104 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Medical Solutions USA, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Medical Solutions USA, Inc. have FDA actions?
Siemens Medical Solutions USA, Inc. has 277 FDA actions in our database, including 173 recalls and 104 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1010-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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