ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
Reported: May 1, 2024 Initiated: February 23, 2024 #Z-1600-2024
Product Description
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
Reason for Recall
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc.
- Units Affected
- 628
- Distribution
- Worldwide distribution - US Nationwide including in the states of AL, AR, CA, CO , CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA , MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WY and the countries of BG, BW, BA, TR, AR, CL, CN, FR, SK, CD, BH, PH, AM, CR, AF, BE, AE, AZ, AO, KR, RO, HU, HR, DK, AU, DZ, CY, PL, BO, AL, NL, CI, BR, CZ, DE, AT, ES, CO, BD, CH, IT, CA, CM, DO, EC, EG, ER, ET, FI, FO, GB, GE, GR, GT, GY, HK, HN, ID, IE, IL, IN, IQ, IR, JO, JP, KE, KW, KZ, LB, LT, LU, LV, LY, MA, MD, ME, MK, MM, MN, MU, MW, MX, MY, NG, NO, NP, NZ, OM, PA, PE, PG, PK, PT, PY, QA, RS, RU, SA, SE, SG, SI, SM, SN, SV, SZ, TH, TN, TT, TW, TZ, UA, UG, UY, UZ, VN, XK, YE, ZA, ZM, ZW.
- Location
- Issaquah, WA
Frequently Asked Questions
What product was recalled? ▼
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 628.
Why was this product recalled? ▼
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2024. Severity: Moderate. Recall number: Z-1600-2024.
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