RecallRadar

FDA Device recall Z-1542-2017

Hitachi Echelon MRI System

On 2017-03-29 the FDA classified a Class II recall of Hitachi Echelon MRI System by Hitachi Medical Systems America, citing image data transferred from the MRI system to a workstation showed errors on the slice position reference image.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1542-2017
ClassificationClass II
Statusterminated
Initiated2015-04-16
Published2017-03-29
Last updated2026-09-13 11:54 UTC
CompanyHitachi Medical Systems America
DistributionUS

Product

Hitachi Echelon MRI System

Reason

Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.

Identifiers

code_info
V001, V002, V003, V004, V005, V006, V007, V008, V009, V010, V011, V012, V013, V014, V015, V016, V017, V018, V020, V021,…V001, V002, V003, V004, V005, V006, V007, V008, V009, V010, V011, V012, V013, V014, V015, V016, V017, V018, V020, V021, V022, V023, V024, V025, V026, V027, V028, V029, V030, V031, V032, V033, V034, V035, V036, V037, V038, V039, V040, V041, V042, V043, V044, V045, V046, V047, V048, V049, V050, V051, V052, V053, V054, V055, V056, V057, V058, V059, V060, V061, V062, V063, V064, V065, V066, V067, V068, V952

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1542-2017%22

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