Philips Ultrasound, Inc: Medical Device Recall in 2025 - (Recall #: Z-2064-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Philips X5-1 Transducer.

Product Classification:

Class II

Date Initiated: May 28, 2025

Date Posted: July 9, 2025

Recall Number: Z-2064-2025

Event ID: 96994

Reason for Recall:

Ultrasound transducer devices were refurbished beyond their useful life.

Status: Ongoing

Product Quantity: 5,230 units

Code Information:

Model No. 989605400802; UDI: (01)00884838061422(21)B2XMDQ, (01)00884838061422(21)B3H27D, (01)00884838061422(21)B2ZXZB, (01)00884838061422(21)B26JC4, (01)00884838061422(21)B3GYXN, (01)00884838061422(21)B2ZXD8, (01)00884838061422(21)B3GJB2, (01)00884838061422(21)B2MQZ3, (01)00884838061422(21)B3L198, (01)00884838061422(21)B3KC2D, (01)00884838061422(21)B3MTN1, (01)00884838061422(21)B2894C; Serial No. B2XMDQ, B3H27D, B2ZXZB, B26JC4, B3GYXN, B2ZXD8, B1CGYC, B3GJB2, B2MQZ3, B3L198, B3KC2D, B3MTN1, B2894C, B1FHTZ.

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.

Voluntary or Mandated:

Voluntary: Firm initiated