Summary
The FDA issued a Class II for ACUSON Juniper Diagnostic Ultrasound System by Siemens Medical Solutions USA, Inc.. Reason: Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable..
Details
Source
Device Recall
External ID
Z-2471-2021
Action Date
2021-09-22
Status
Terminated
Category
device
Product Description
ACUSON Juniper Diagnostic Ultrasound System
Lot/Code Info: Model Number: 11335791 UDI: (01)04056869152059 (21)123456 (240)11335791 (422)410 Firmware version 3.8 for rev. 7 U.S. Serial Number: 555606; O.U.S. Serial Numbers: 550975; 552770; 553629; 553951; 555060; 555601; 555602; 555604; 555605; 555610; 555611; 555612; 555613; 555626; O.U.S. Inactive Serial Numbers: 555603; 555607;
Quantity Affected: 15 systems
Reason for Recall
Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.
Distribution
Worldwide distribution - U.S. Nationwide distribution in the Puerto Rico and the countries of Bosnia Herzegovina, Canada, Colombia, Germany, Greece, Italy, North Macedonia, Poland, and Slovenia.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-12
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 142 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-2471-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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