ACUSON Juniper Diagnostic Ultrasound System recall
ACUSON Juniper Diagnostic Ultrasound System
Why was ACUSON Juniper Diagnostic Ultrasound System recalled?
Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
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;
- Product
- ACUSON Juniper Diagnostic Ultrasound System
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 15 systems
- 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.
- Recall date
- September 22, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)