ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasou
FDA device recall Z-3217-2024 · posted 2024-09-24 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- 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
- Action taken
- On 8/15/2024, correction notices were distributed to customers who were asked to do the following: To avoid potential misdiagnosis by an under-represented volume flow measurement value, use the factory default display configuration of l/min (liters per minute). Review of previous examination results ONLY if a clinical assessment reviewed a volume flow measurement(s) with the unit of measurement configured to display a value in milliliters. Firm's Customer Service Engineer will contact you to schedule a facility visit to update the system or inform you of a remote update when the software update is available. The software update is currently under development and estimated to be available in the summer of 2024. Ensure that all users of ACUSON Juniper and ACUSON Maple systems within your organization, and others who may need to be informed, receive the safety relevant information provided with this notice and take the actions specified herein. If you have further questions, please contact the firm's Ultrasound Service Customer Care Center at 1-800-888-7436.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- IYN
- Quantity affected
- 321
- Distribution
- US: MS, WA, TX, NJ, GA, PN, NY, AL, MN, NE, IN, CT, CA, IL, TN, WI, ND, NM, AR, NC, PR, RI, WY, MD, FL, HI, AZ, SC, MO, OK, VA, ME, KS, MI, LA, IA, OH, SD, NH, KY, AL, OR, MA, GU. OUS: Afghanistan, Al
- Date initiated
- 2024-08-15
- Date posted
- 2024-09-24
- Location
- Issaquah, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System (K232617) | Siemens Medical Solutions USA, Inc. | 2023-09-26 |