ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
FDA device recall Z-1200-2018 · posted 2018-03-26 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment.
- Action taken
- Undated recall letters were issued via email (if they had an email address for the customer) or via certified mail (if no email address was available) on 3/5/2018.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 229 systems
- Distribution
- Distribution was made to medical facilities in AZ, CA, CT, FL, IL, IN, KS, KY, MI, MN, MO, NJ, NY, NC, OH, PA, TX, VA, and WA. There was no military/government distribution. Foreign distribution was m
- Date initiated
- 2018-03-05
- Date posted
- 2018-03-26
- Date terminated
- 2021-02-26
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Acuson SC2000 Diagnostic Ultrasound System (K170315) | Siemens Medi Cal Solutions, Inc. | 2017-04-04 |