Hitachi Healthcare Americas recalls

Hitachi Healthcare Americas has 4 recalls on record with the FDA and USDA, the earliest in 2021 and the latest reported on 1 Sep 2021. 1 is still ongoing. The most frequent reason is foreign material.

Total recalls4since 2021

Last 12 months0reported

Class I00% of total

Ongoing1latest 1 Sep 2021

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 100%Class III 0 0%

Why hitachi healthcare americas is recalled

Foreign Material375%
Sterility125%

Product types

Imaging Equipment375%
Surgical Instruments125%

By year

20214100%

Ongoing hitachi healthcare americas recalls

1 active

Reported	Class	Recall	Company	Reason	Where
25 Aug 2021Device	CLASS II	Model L43K Intraoperative Probe-For the diagnostic ultrasound recalled	Hitachi Healthcare Americas	Sterility	Nationwide

All hitachi healthcare americas recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
1 Sep 2021Device	CLASS II	Echelon Oval MRI System recalled by Hitachi Healthcare Americas	Hitachi Healthcare Americas	Foreign Material	Nationwide
1 Sep 2021Device	CLASS II	Echelon MRI System recalled by Hitachi Healthcare Americas	Hitachi Healthcare Americas	Foreign Material	Nationwide
1 Sep 2021Device	CLASS II	Oasis MRI System recalled by Hitachi Healthcare Americas	Hitachi Healthcare Americas	Foreign Material	Nationwide
25 Aug 2021Device	CLASS II	Model L43K Intraoperative Probe-For the diagnostic ultrasound recalled	Hitachi Healthcare Americas	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.