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Recall Observatory FDA recall evidence

Device product

Philips VL13-5 Transducer.

Z-2063-2025

May 28, 2025

Class II

Product summary

Firm
Philips Ultrasound, Inc
Event
Event 96994
Status
Ongoing
Classification
Class II
Quantity
5,230 units
Official record key
device-enforcement:Z-2063-2025

Official wording

Reason: Ultrasound transducer devices were refurbished beyond their useful life.

Code information: Model No. 989605409592, 989605372211, 989605372213; UDI: (01)00884838061606(21)B1C23Z, (01)00884838061606(21)B252D4, (01)00884838061606(21)B12ZWV, (01)00884838061606(21)B12QQC, (01)00884838061606(21)B23P58, (01)00884838061606(21)B0X3RL, (01)00884838061606(21)B12RN0, (01)00884838061606(21)B13BCL, (01)00884838061606(21)B1F233, (01)00884838061606(21)B2DWNC, (01)00884838061606(21)B12RN4, (01)00884838061606(21)B12ZTJ, (01)00884838061606(21)B1XR83, (01)00884838061606(21)B13DFT, (01)00884838061606(21)B12QVB, (01)00884838061606(21)B18LZX, (01)00884838067493(21)03FNNG, (01)00884838067493(21)038VY0, (01)00884838067493(21)03926P, (01)00884838067493(21)0367GM, (01)00884838067493(21)036BRP; Serial No. B1C23Z, B252D4, B12ZWV, B12QQC, B23P58, B0X3RL, B12RN0, B13BCL, B1F233, B2DWNC, B12RN4, B12ZTJ, B1XR83, B13DFT, B12QVB, B18LZX, 03FNNG, 038VY0, 03926P, 0367GM, 0399WM, 036BRP, 039250.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Ultrasound transducer devices were refurbished beyond their useful life.