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Philips L8-4 Transducer recallZ-2056-2025 · Philips Ultrasound, Inc · initiated May 28, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Ultrasound, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Ultrasound transducer devices were refurbished beyond their useful life.

FDA root cause category: Process control

What the company is doing

An URGENT Medical Device Recall notification dated 5/28/25 was mailed to consignees. The notification informs consignees that Philips Ultrasound will be replacing transducers that were refurbished beyond their useful life with a new transducer. Consignees may continue to use affected devices while awaiting replacement; consignees should use devices in accordance with their intended use and per the instructions provided int he User Manual. Users should perform visual inspection and electrical safety testing as indicated in the User Manual; if a device does not pass inspection, it should be removed from clinical use. Consignees are asked to return the completed Response Form and circulate the provided notification to all users to ensure awareness. A copy of the recall notification should be kept with affected transducers until their replacement. Consignees with any questions can contact the Customer Care Solutions Center at 1-800-722-9377. Additional consignees were identified and notified via URGENT Medical Device Recall Notification on 9/5/25.

Recall details

Recall number
Z-2056-2025
Status
Open, Classified
Initiated by the company
May 28, 2025
Posted by the FDA
Jul 2, 2025
Recalling firm
Philips Ultrasound, Inc
Quantity
5,230 units
Product code
ITX
FDA submissions
K030455, K043535
Distribution
Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, United Arab Emirates, Venezuela, Vietnam.

Product description

Philips L8-4 Transducer.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Model No. 989605440811, 989605440812; UDI: (01)00884838067684(21)B0LZNN, (01)00884838067684(21)03BPVM, (01)00884838067684(21)02KMFZ, (01)00884838067684(21)02HJDK, (01)00884838067684(21)02FWNQ, (01)00884838067684(21)02KKZT, (01)00884838067684(21)03H7GL, (01)00884838067684(21)02LTKK, (01)00884838067684(21)02H2JM, (01)00884838067684(21)02KKVB, (01)00884838067684(21)038XYV, (01)00884838067684(21)02DLVR, (01)00884838067684(21)02CCM5, (01)00884838067684(21)02LT6G, (01)00884838067684(21)02KMKK, (01)00884838067684(21)02V8VD, (01)00884838067684(21)037Z2B, (01)00884838067684(21)02NK5J; Serial No. B0LZNN, 03BPVM, 02KMFZ, 02HJDK, 02KLBP, 02FWNQ, 02RTF9, 02KKZT, 03H7GL, 02LTKK, 02H2JM, 02KKVB, 038XYV, 02H34T, 02DLVR, 02CCM5, 02LT6G, 02KMKK, 02V8VD, 02JC66, 02V016, 037Z2B, 02NK5J.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 96994).

Sources and updates

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