510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-2402-2025Class III

TRANSDUCER L12-5 Transducer Probe

Philips North America LLC / initiated 2025-07-03 / Open, Classified / root cause: design
FDA source (opens on fda.gov)

Philips Ultrasound, Inc began a recall of TRANSDUCER L12-5 Transducer Probe 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-2402-2025
Classification
Class III
Status
Open, Classified
Initiated
Posted
Recalling firm
Philips North America LLC
Product
TRANSDUCER L12-5 Transducer Probe
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
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 7/3/25, 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
171,322 units
Distribution
US Nationwide distribution.
Product codes and lots
Model No. 989605408174; UDI: N/A; Serial No. B1D3VM.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2402-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2346-2025Class IIIOngoingVoluntary: Firm initiated
Z-2347-2025Class IIIOngoingVoluntary: Firm initiated
Z-2348-2025Class IIIOngoingVoluntary: Firm initiated
Z-2349-2025Class IIIOngoingVoluntary: Firm initiated
Z-2350-2025Class IIIOngoingVoluntary: Firm initiated
Z-2351-2025Class IIIOngoingVoluntary: Firm initiated
Z-2352-2025Class IIIOngoingVoluntary: Firm initiated
Z-2353-2025Class IIIOngoingVoluntary: Firm initiated
Z-2354-2025Class IIIOngoingVoluntary: Firm initiated
Z-2355-2025Class IIIOngoingVoluntary: Firm initiated
Z-2356-2025Class IIIOngoingVoluntary: Firm initiated
Z-2357-2025Class IIIOngoingVoluntary: Firm initiated
Z-2358-2025Class IIIOngoingVoluntary: Firm initiated
Z-2359-2025Class IIIOngoingVoluntary: Firm initiated
Z-2360-2025Class IIIOngoingVoluntary: Firm initiated
Z-2361-2025Class IIIOngoingVoluntary: Firm initiated
Z-2362-2025Class IIIOngoingVoluntary: Firm initiated
Z-2363-2025Class IIIOngoingVoluntary: Firm initiated
Z-2364-2025Class IIIOngoingVoluntary: Firm initiated
Z-2365-2025Class IIIOngoingVoluntary: Firm initiated
Z-2366-2025Class IIIOngoingVoluntary: Firm initiated
Z-2367-2025Class IIIOngoingVoluntary: Firm initiated
Z-2368-2025Class IIIOngoingVoluntary: Firm initiated
Z-2369-2025Class IIIOngoingVoluntary: Firm initiated
Z-2370-2025Class IIIOngoingVoluntary: Firm initiated
Z-2371-2025Class IIIOngoingVoluntary: Firm initiated
Z-2372-2025Class IIIOngoingVoluntary: Firm initiated
Z-2373-2025Class IIIOngoingVoluntary: Firm initiated
Z-2374-2025Class IIIOngoingVoluntary: Firm initiated
Z-2375-2025Class IIIOngoingVoluntary: Firm initiated
Z-2376-2025Class IIIOngoingVoluntary: Firm initiated
Z-2377-2025Class IIIOngoingVoluntary: Firm initiated
Z-2378-2025Class IIIOngoingVoluntary: Firm initiated
Z-2379-2025Class IIIOngoingVoluntary: Firm initiated
Z-2380-2025Class IIIOngoingVoluntary: Firm initiated
Z-2381-2025Class IIIOngoingVoluntary: Firm initiated
Z-2382-2025Class IIIOngoingVoluntary: Firm initiated
Z-2383-2025Class IIIOngoingVoluntary: Firm initiated
Z-2384-2025Class IIIOngoingVoluntary: Firm initiated
Z-2385-2025Class IIIOngoingVoluntary: Firm initiated
Z-2386-2025Class IIIOngoingVoluntary: Firm initiated
Z-2387-2025Class IIIOngoingVoluntary: Firm initiated
Z-2388-2025Class IIIOngoingVoluntary: Firm initiated
Z-2389-2025Class IIIOngoingVoluntary: Firm initiated
Z-2390-2025Class IIIOngoingVoluntary: Firm initiated
Z-2391-2025Class IIIOngoingVoluntary: Firm initiated
Z-2392-2025Class IIIOngoingVoluntary: Firm initiated
Z-2393-2025Class IIIOngoingVoluntary: Firm initiated
Z-2394-2025Class IIIOngoingVoluntary: Firm initiated
Z-2395-2025Class IIIOngoingVoluntary: Firm initiated
Z-2396-2025Class IIIOngoingVoluntary: Firm initiated
Z-2397-2025Class IIIOngoingVoluntary: Firm initiated
Z-2398-2025Class IIIOngoingVoluntary: Firm initiated
Z-2399-2025Class IIIOngoingVoluntary: Firm initiated
Z-2400-2025Class IIIOngoingVoluntary: Firm initiated
Z-2401-2025Class IIIOngoingVoluntary: Firm initiated
Z-2402-2025Class IIIOngoingVoluntary: Firm initiated
Z-2403-2025Class IIIOngoingVoluntary: Firm initiated
Z-2404-2025Class IIIOngoingVoluntary: Firm initiated
Z-2405-2025Class IIIOngoingVoluntary: Firm initiated
Z-2406-2025Class IIIOngoingVoluntary: Firm initiated
Z-2407-2025Class IIIOngoingVoluntary: Firm initiated
Z-2408-2025Class IIIOngoingVoluntary: Firm initiated
Z-2409-2025Class IIIOngoingVoluntary: Firm initiated
Z-2410-2025Class IIIOngoingVoluntary: Firm initiated
Z-2411-2025Class IIIOngoingVoluntary: Firm initiated
Z-2412-2025Class IIIOngoingVoluntary: Firm initiated
Z-2413-2025Class IIIOngoingVoluntary: Firm initiated
Z-2414-2025Class IIIOngoingVoluntary: Firm initiated