Z-2056-2025Class II
Philips L8-4 Transducer
Philips North America LLC / initiated 2025-05-28 / Open, Classified / root cause: manufacturing process
Philips Ultrasound, Inc began a recall of Philips L8-4 Transducer on . FDA classified it as Class II and gives the reason as "Ultrasound transducer devices were refurbished beyond their useful life". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2056-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Philips North America LLC
- Product
- Philips L8-4 Transducer.
- Product code
- ITX Transducer, Ultrasonic, Diagnostic
- Reason for recall
- Ultrasound transducer devices were refurbished beyond their useful life.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- 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.
- Quantity in commerce
- 5,230 units
- 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 codes and lots
- 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.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2048-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2049-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2050-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2051-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2052-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2053-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2054-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2055-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2056-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2057-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2058-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2059-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2060-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2061-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2062-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2063-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2064-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2065-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2066-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2067-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2068-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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