🔍 RecallPedia

Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult TEE; Cardiac Neonatal; Cardiac Pediatric; Cardiac Pediatric TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications

Class I - Dangerous
🏥 Medical Devices Recalled: June 11, 2014 Hitachi Aloka Medical Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 202M4896 202M4891 202M4893 202M4897 202M4898 202M4894
  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:
Hitachi Aloka Medical, Ltd.
Reason for Recall:
Loosened monitor arm.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult TEE; Cardiac Neonatal; Cardiac Pediatric; Cardiac Pediatric TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications

Product Codes/Lot Numbers:

Serial Numbers: 202M4896 202M4891 202M4893 202M4897 202M4898 202M4894

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1696-2017