Philips L9-3 Transducer (Philips) – Life Refurbishment Problem (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips L9-3 Transducer.
Brand
Philips Ultrasound, Inc
Lot Codes / Batch Numbers
Model No. 989605353301, 989605353303, 989605387361, UDI: N/A, Serial No. B0ZTD1, 03F40C, 03923H, 0314BQ, 03712H, 033HGC, 03CJ9M, 035JY0, 03CFTH, 0399XP, 030FNL, 037R81, 02ZH61, 0358PF, 033JGV, 03FN82, 03230B, 03145Y, 02XYB3, 02XWH4, 02Z1D9, 03591C, 0359Q1, 03598Y, 035JVM, 02WVF0, 02WYT1, 03CFPG, 02XWN1, 02ZJR6, 02NV7G, 0305WC, 036XY3, 02XY9D, 03FNPD, 02ZJPH, B08PVN, 0373HX, B0NP6L, 03F364, 03922W, 02X173, 02WYQX, 02ND56, 0367GW, 0315P3, 02QMTL, 038W72, 03315L, 0358PV, 033JK7, 03128V, 032297.
Products Sold
Model No. 989605353301, 989605353303, 989605387361; UDI: N/A; Serial No. B0ZTD1, 03F40C, 03923H, 0314BQ, 03712H, 033HGC, 03CJ9M, 035JY0, 03CFTH, 0399XP, 030FNL, 037R81, 02ZH61, 0358PF, 033JGV, 03FN82, 03230B, 03145Y, 02XYB3, 02XWH4, 02Z1D9, 03591C, 0359Q1, 03598Y, 035JVM, 02WVF0, 02WYT1, 03CFPG, 02XWN1, 02ZJR6, 02NV7G, 0305WC, 036XY3, 02XY9D, 03FNPD, 02ZJPH, B08PVN, 0373HX, B0NP6L, 03F364, 03922W, 02X173, 02WYQX, 02ND56, 0367GW, 0315P3, 02QMTL, 038W72, 03315L, 0358PV, 033JK7, 03128V, 032297.
Philips Ultrasound, Inc is recalling Philips L9-3 Transducer. due to Ultrasound transducer devices were refurbished beyond their useful life.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Ultrasound transducer devices were refurbished beyond their useful life.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026