Drug recall
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper…
FDA recall event 95254 · Class II · Siemens Medical Solutions USA, Inc.
Key facts
| Event ID | 95254 |
|---|---|
| Recall numbers | Z-3215-2024, Z-3216-2024, Z-3217-2024 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Product type | Devices |
| Products | ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software., ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software, ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Aug 15, 2024 |
| Report date | Oct 2, 2024 |
| City | Issaquah |
| State | WA |
| Country | United States |
| FEI number | 3023245 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: