Fujifilm Medical Systems U recalls

Fujifilm Medical Systems U has 37 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 9 Jun 2021. 3 are still ongoing.

Total recalls37since 2015

Last 12 months0reported

Class I00% of total

Ongoing3latest 9 Jun 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 36 97%Class III 1 3%

Why fujifilm medical systems u is recalled

Product types

By year

2021616%
202025%
201925%
2018616%
2017514%
2016924%
2015719%

Ongoing fujifilm medical systems u recalls

3 active

Reported	Class	Recall	Company	Reason	Where
14 Apr 2021Device	CLASS II	Synapse PACS - Radiological Image Processing System recalled	Fujifilm Medical Systems U	Device Malfunction	Nationwide
27 Jan 2021Device	CLASS II	Synapse PACS recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Device Malfunction	Nationwide
8 Jul 2020Device	CLASS II	Fujifilm Synapse PACS recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Device Malfunction	Nationwide

All fujifilm medical systems u recalls, newest first

37 total

Reported	Class	Recall	Company	Reason	Where
9 Jun 2021Device	CLASS II	Synapse Cardiovascular (Synapse CV) recalled	Fujifilm Medical Systems U	Device Malfunction	Nationwide
21 Apr 2021Device	CLASS II	¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit recalled	Fujifilm Medical Systems U	Device Malfunction	6 states
14 Apr 2021Device	CLASS II	Synapse PACS - Radiological Image Processing System recalled	Fujifilm Medical Systems U	Device Malfunction	Nationwide
3 Feb 2021Device	CLASS II	Fujifilm Synapse Pacs recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Device Malfunction	Nationwide
3 Feb 2021Device	CLASS III	Wako Hdl-c/Ldl-c Calibrator recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Other	Nationwide
27 Jan 2021Device	CLASS II	Synapse PACS recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Device Malfunction	Nationwide
28 Oct 2020Device	CLASS II	Synapse PACS recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Device Malfunction	Nationwide
8 Jul 2020Device	CLASS II	Fujifilm Synapse PACS recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Device Malfunction	Nationwide
11 Sep 2019Device	CLASS II	Fujifilm FDR Go Plus mobile X-ray system recalled	Fujifilm Medical Systems U	Other	Nationwide
27 Mar 2019Device	CLASS II	Fujifilm FDR Go PLUS, Mobile X-Ray System recalled	Fujifilm Medical Systems U	Other	Nationwide
28 Feb 2018Device	CLASS II	Aspire HD (for FDR-1000AWS) The Fujifilm Digital recalled	Fujifilm Medical Systems U	Device Malfunction	CT
28 Feb 2018Device	CLASS II	Aspire HD Plus, Aspire HD-s recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Device Malfunction	CT
28 Feb 2018Device	CLASS II	Aspire Cristalle (for Fdr-3000AWS) The Fujifilm Digital recalled	Fujifilm Medical Systems U	Device Malfunction	CT
28 Feb 2018Device	CLASS II	Fuji Computed Radiography Mammography Suite, Fcrms recalled	Fujifilm Medical Systems U	Device Malfunction	CT
24 Jan 2018Device	CLASS II	Aspire HD Plus (FDR MS-2500) recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Other	CT
24 Jan 2018Device	CLASS II	Aspire Cristalle (FDR MS-3500) Mammography machine recalled	Fujifilm Medical Systems U	Other	CT
20 Dec 2017Device	CLASS II	Fujifilm FDR Visionary Suite with CH recalled	Fujifilm Medical Systems U	Device Malfunction	CT
4 Oct 2017Device	CLASS II	Fujinon Ed-530xt recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Packaging Defects	Nationwide
20 Sep 2017Device	CLASS II	Fujifilm Endoscope recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Processing Deviation	Nationwide
20 Sep 2017Device	CLASS II	Fujifilm Endoscope recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Processing Deviation	Nationwide
19 Jul 2017Device	CLASS II	Ultrasonic Endoscope recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Other	AL, HI, MO
19 Oct 2016Device	CLASS II	Fujifilm Synapse PACS recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Device Malfunction	Nationwide
7 Sep 2016Device	CLASS II	Fujifilm Digital Mammography System Aspire HD recalled	Fujifilm Medical Systems U	Other	HI, NC
29 Jun 2016Device	CLASS II	Fujifilm Synapse PACS recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Device Malfunction	6 states
8 Jun 2016Device	CLASS II	Endoscope ED-450XT5 Operation Manual: Cleaning recalled	Fujifilm Medical Systems U	Other	Nationwide
8 Jun 2016Device	CLASS II	Endoscope; ED-530XT Operation Manual 'Operation recalled	Fujifilm Medical Systems U	Other	Nationwide
8 Jun 2016Device	CLASS II	Endoscope ED-250XT5 Operations Manual recalled	Fujifilm Medical Systems U	Other	Nationwide
8 Jun 2016Device	CLASS II	Endoscope ED-450XL5 Operation Manual: Cleaning recalled	Fujifilm Medical Systems U	Other	Nationwide
8 Jun 2016Device	CLASS II	Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection recalled	Fujifilm Medical Systems U	Other	Nationwide
11 May 2016Device	CLASS II	Smart CR Digital Computed Radiography System recalled	Fujifilm Medical Systems U	Device Malfunction	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.