Drug recall
Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and…
FDA recall event 84902 · Class II · Philips Ultrasound Inc
Key facts
| Event ID | 84902 |
|---|---|
| Recall numbers | Z-1841-2020, Z-1842-2020, Z-1843-2020, Z-1844-2020 |
| Recalling firm | Philips Ultrasound Inc |
| Product type | Devices |
| Products | Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow…, Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body…, Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used with: iE33 Utrasound System - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly…, Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure… |
| Initiation date | Aug 30, 2019 |
| Report date | May 13, 2020 |
| Termination date | Nov 27, 2024 |
| City | Bothell |
| State | WA |
| Country | United States |
| FEI number | 3019216 |
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: