Recalls / —

—#214257

Product

Philips C5-1 Transducer.

FDA product code

ITX — Transducer, Ultrasonic, Diagnostic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K091804, K111513, K123754, K130499, K132304

Affected lot / code info

Model No.989605412042, 989605438541, 989605365001, 989605365003; UDI: (01)00884838061613(21)B1M9V1, (01)00884838061613(21)B13H1L; Serial No. B1M9V1, B142ZP, B13H1L, B1LGKZ, B0T0M5, 03DBJJ, 036JBL, B01RWL, B01MZT, 0393MP, 03DWZC, 03FVH9, B02T1M, 03BM2V, B0FN6H, B08TM5, 039D7K, B00RZ7, 03BW39, 0397YZ, B0HG6F, 03937G, 03D7JL, 03C9YZ, 039CNL, 03DVPT, 037VBM, 03DYMH, 03BM6P, B0D9HC, 03BXT8, 03BLG3.

Why it was recalled

Ultrasound transducer devices were refurbished beyond their useful life.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Philips Ultrasound, Inc

Address

1 Echo Dr, Reedsville, Pennsylvania 17084-8603

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2025-05-28

Posted by FDA

2025-07-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #214257. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.