Philips X5-1 Transducer.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips Ultrasound, Inc
Reason for Recall:
Ultrasound transducer devices were refurbished beyond their useful life.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Philips X5-1 Transducer.

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2064-2025

Related Recalls

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Philips Ultrasound

Class I - Dangerous

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Jul 3, 2025 Other Medical Devices Nationwide View Details →