CLASS III ONGOING Device recall · Reported 1 Apr 2026 · FDA Enforcement Report
Philips Mini Multi TEE Ultrasound Transducer recalled
Philips Ultrasound is recalling Philips Mini Multi TEE Ultrasound Transducer, distributed nationwide in the US. The recall was initiated on 5 Sep 2025 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1622-2026
- FDA event ID
- 97643
- Recalling firm
- Philips Ultrasound, Reedsville, PA
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 5 Sep 2025
- FDA classified
- 24 Mar 2026
- Reported
- 1 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 5 Sep 2025 | Recall initiated by company | |
| 24 Mar 2026 | Classified by FDA | +200 days |
| 1 Apr 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product as listed by the FDA
Philips Mini Multi TEE Ultrasound Transducer
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Which lots are affected?
Model No. 989605439241, 989605439242, 21381A; UDI: (01)00884838067547(21)B093BQ, (01)00884838067547(21)B0988T, (01)00884838067547(21)02P6MY, (01)00884838067547(21)039M2Q, (01)00884838067547(21)0319CQ, (01)00884838067547(21)B01639; Serial No. 02GXR0, B093BQ, B0988T, 02P6MY, 039M2Q, 0341YT, 0319CQ, 028NZW, 02H0L8, B01639, 039M2M.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 97643This product is part of a recall event; the main page for the event is Philips S5-2 Ultrasound Transducer recalled by Philips Ultrasound.
More recalls from Philips Ultrasound
All 109| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips EPIQ Elite Diagnostic Ultrasound System recalled | Philips Ultrasound | Labeling Errors | Nationwide |
| Device | CLASS III | Philips L12-5 Ultrasound Transducer recalled by Philips Ultrasound | Philips Ultrasound | Other | Nationwide |
| Device | CLASS III | Philips C9-4 Ultrasound Transducer recalled by Philips Ultrasound | Philips Ultrasound | Other | Nationwide |
| Device | CLASS III | Philips X7-2 Ultrasound Transducer recalled by Philips Ultrasound | Philips Ultrasound | Other | Nationwide |
| Device | CLASS III | Philips 3D6-2 Ultrasound Transducer recalled by Philips Ultrasound | Philips Ultrasound | Other | Nationwide |
Other Imaging Equipment recalls
All 2,341| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips EPIQ Elite Diagnostic Ultrasound System recalled | Philips Ultrasound | Labeling Errors | Nationwide |
| Device | CLASS II | GmbH Spectralis with Flex Module recalled by Heidelberg Engineering | Heidelberg Engineering | Potency & Assay | Nationwide |
| Device | CLASS II | Core Services Hub V8, a set of backend services including recalled | GE Healthcare | Other | Nationwide |
| Device | CLASS II | Centricity PACS V2, V3, V4, V6, V7 recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Haylard Univ Imaging Biopsy Trucustom kits recalled by Avid Medical | Avid Medical | Sterility | 4 states |