510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1627-2026Class III

Philips X3-1 Ultrasound Transducer

Philips North America LLC / initiated 2025-09-05 / Open, Classified / root cause: design
FDA source (opens on fda.gov)

Philips Ultrasound, Inc began a recall of Philips X3-1 Ultrasound Transducer on . FDA classified it as Class III and gives the reason as "To provide clarification and labelling to define the useful life of ultrasound transducers in the field". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-1627-2026
Classification
Class III
Status
Open, Classified
Initiated
Posted
Recalling firm
Philips North America LLC
Product
Philips X3-1 Ultrasound Transducer
Product code
ITX Transducer, Ultrasonic, Diagnostic
Reason for recall
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Root cause tag
design
FDA root cause
Device Design
Action
An URGENT Medical Device Correction Notice, dated 8/19/25, was mailed to consignees. This notice instructs consignees to locate all Philips Ultrasound transducers in their facility and enter their serial numbers into https://www.transducer.philips.com to obtain the manufacturing certificate for each of their devices. This certificate should be retained with its system documentation. Using the manufacturing certificate consignees are to calculate the useful life of their device. The expected useful life for Transesophageal transducers, X-Matrix transducers, and Lumify transducers is 5 years; The expected useful life for Endocavity transducers and Transcutaneous transducers is 7 years. If a transducer has exceeded its useful life, consignees are instructed to conduct transducer performance tests or contact Philips for guidance. Consignees are asked to complete and return the provided response form and circulate the recall notification to device users for their awareness. Consignees with any questions can contact Philips Customer Care Solutions Center at 1-800-722-9377.
Quantity in commerce
17 units
Distribution
US Nationwide distribution.
Product codes and lots
Model No. 989605440742, 989603002321, 989605388101, 989605440741; UDI: (01)00884838067615(21)033TVZ, (01)00884838067615(21)02Q8R3, (01)00884838067615(21)02VLZV, (01)00884838067615(21)02WND0, (01)00884838067615(21)02ZWBH, (01)00884838067615(21)02GP3C, (01)00884838067615(21)03DTL6, (01)00884838067615(21)02JK1H, (01)00884838067615(21)02VMJ6, (01)00884838067615(21)035Z89, (01)00884838067615(21)031C21, (01)00884838067615(21)02JL3W, (01)00884838067615(21)03C066, (01)00884838067615(21)02JK8D; Serial No. 033TVZ, 02Q8R3, 02VLZV, 02WND0, 02ZWBH, 02GP3C, 02YHTG, 02YHPN, 03DTL6, 02JK1H, 02VMJ6, 035Z89, 031C21, 038NQC, 02JL3W, 03C066, 02JK8D.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1627-2026
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1618-2026Class IIIOngoingVoluntary: Firm initiated
Z-1619-2026Class IIIOngoingVoluntary: Firm initiated
Z-1620-2026Class IIIOngoingVoluntary: Firm initiated
Z-1621-2026Class IIIOngoingVoluntary: Firm initiated
Z-1622-2026Class IIIOngoingVoluntary: Firm initiated
Z-1623-2026Class IIIOngoingVoluntary: Firm initiated
Z-1624-2026Class IIIOngoingVoluntary: Firm initiated
Z-1625-2026Class IIIOngoingVoluntary: Firm initiated
Z-1626-2026Class IIIOngoingVoluntary: Firm initiated
Z-1627-2026Class IIIOngoingVoluntary: Firm initiated
Z-1628-2026Class IIIOngoingVoluntary: Firm initiated