Recall Z-3216-2024— Siemens Medical Solutions USA, Inc.
Class II · Ongoing
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2024-08-15. It names one FDA 510(k) clearance: K210743. Product: ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software. Reason: If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management.
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-15
- Firm location
- Issaquah, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Reason for recall
If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
Data sourced from openFDA. This site is unofficial and independent of the FDA.