The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1696-2017·Announced 2017-04-05

Hitachi Aloka Prosound F75 Ultrasound System Recalled for Loosened Monitor Arm

Hitachi Aloka Medical is recalling Prosound F75 ultrasound systems because the monitor arm may loosen. Affected units were distributed to specific US states.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural component (monitor arm) that may loosen, posing a risk of harm (e.g., falling equipment) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Hitachi Aloka Medical, Ltd. is recalling Prosound F75 diagnostic ultrasound systems due to a defect where the monitor arm may loosen. The device is intended for use by trained personnel for various diagnostic ultrasound evaluations, including fetal, abdominal, and cardiac applications.

The recall affects units with serial numbers 202M4896, 202M4891, 202M4893, 202M4897, 202M4898, and 202M4894. These units were distributed nationwide to Pennsylvania, Texas, Florida, Arizona, Indiana, and Ohio.

The FDA has classified this as a Class II recall. Users should contact Hitachi Aloka Medical for instructions on how to address the defect.

The recalled product

Product
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…
Manufacturer
Hitachi Aloka Medical, Ltd.
Category
Medical Device — Diagnostic Ultrasound
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

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