Imaging Equipment recalls

2,336 medical device recalls in the imaging equipment category are on file with the FDA, from 2012 to 9 Sep 2026.

Total recalls2,336since 2012

Last 12 months162reported

Class I412% of total

Ongoing691latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

7Oct '24 6 31 5Jan '25 6 12 5Apr 1 2 13Jul 22 2 74Oct 18 4 6Jan '26 6 4 14Apr 8 10 7Jul 7 4

Severity split

Class I 41 2%Class II 2,265 97%Class III 30 1%

Why imaging equipment is recalled

Companies

Siemens Medical Solutions USA52623%
Philips Medical Systems (Cleveland)25511%
GE Healthcare2089%
GE Medical Systems954%
Philips North America864%
Philips Medical Systems Nederlands753%
MEDLINE INDUSTRIES, LP - Northfield603%
Sedecal542%

By year

2026663%
20251647%
20241557%
20231356%
2022864%
20211506%
20201235%
20192159%
201824010%
20171446%

Ongoing imaging equipment recalls

691 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled	Canon Medical System, USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederland B.v	Lead & Heavy Metals
19 Aug 2026Device	CLASS II	navify Digital Pathology (on-prem) v2.5 recalled	Ventana Medical Systems	Device Malfunction	Nationwide

All imaging equipment recalls, newest first

2,336 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled	Canon Medical System, USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederland B.v	Lead & Heavy Metals
19 Aug 2026Device	CLASS II	navify Digital Pathology (on-prem) v2.5 recalled	Ventana Medical Systems	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Allura Xper FD recalled by Philips Medical Systems	Philips Medical Systems Nederland B.v	Other	Nationwide
12 Aug 2026Device	CLASS II	Merge OrthoPACS, medical imaging diagnostic workstation recalled	Merge Healthcare	Other	Nationwide
12 Aug 2026Device	CLASS II	Merge PACS, medical imaging diagnostic workstation recalled	Merge Healthcare	Other	Nationwide
12 Aug 2026Device	CLASS II	Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 recalled	Copan WASP	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.