Imaging Equipment recalls

2,341 medical device recalls in the imaging equipment category are on file with the FDA, from 2012 to 30 Sep 2026.

Total recalls2,341since 2012

Last 12 months167reported

Class I422% of total

Ongoing696latest 30 Sep 2026

Recalls per month, last 24 months

click a bar for that month

6Nov '24 31 5 6Feb 12 5 1May 2 13 22Aug 2 74 18Nov 4 6 6Feb 4 14 8May 10 7 7Aug 9 0

Severity split

Class I 42 2%Class II 2,269 97%Class III 30 1%

Why imaging equipment is recalled

Companies

Siemens Medical Solutions USA52622%
Philips Medical Systems (Cleveland)25511%
GE Healthcare2109%
GE Medical Systems954%
Philips North America864%
Philips Medical Systems Nederlands753%
Medline Industries LP - Northfield603%
Sedecal542%

By year

2026713%
20251647%
20241557%
20231356%
2022864%
20211506%
20201235%
20192159%
201824010%
20171446%

Ongoing imaging equipment recalls

696 active

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Philips EPIQ Elite Diagnostic Ultrasound System recalled	Philips Ultrasound	Labeling Errors	Nationwide
30 Sep 2026Device	CLASS II	GmbH Spectralis with Flex Module recalled by Heidelberg Engineering	Heidelberg Engineering	Potency & Assay	Nationwide
23 Sep 2026Device	CLASS II	Core Services Hub V8, a set of backend services including recalled	GE Healthcare	Other	Nationwide
23 Sep 2026Device	CLASS II	Centricity PACS V2, V3, V4, V6, V7 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	Haylard Univ Imaging Biopsy Trucustom kits recalled by Avid Medical	Avid Medical	Sterility	4 states
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide

All imaging equipment recalls, newest first

2,341 total

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Philips EPIQ Elite Diagnostic Ultrasound System recalled	Philips Ultrasound	Labeling Errors	Nationwide
30 Sep 2026Device	CLASS II	GmbH Spectralis with Flex Module recalled by Heidelberg Engineering	Heidelberg Engineering	Potency & Assay	Nationwide
23 Sep 2026Device	CLASS II	Core Services Hub V8, a set of backend services including recalled	GE Healthcare	Other	Nationwide
23 Sep 2026Device	CLASS II	Centricity PACS V2, V3, V4, V6, V7 recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	Haylard Univ Imaging Biopsy Trucustom kits recalled by Avid Medical	Avid Medical	Sterility	4 states
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	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 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 Nederl	Potency & Assay
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 Nederl	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
12 Aug 2026Device	CLASS II	MC2 Portable X-Ray System recalled by Oxos Medical	Oxos Medical	Device Malfunction	Nationwide
29 Jul 2026Device	CLASS II	SnapshotGLO Wound Imaging Device recalled by Kent Imaging	Kent Imaging	Device Malfunction	Nationwide
22 Jul 2026Device	CLASS II	Optima XR240amx, Mobile Digital Radiographic System recalled	GE Medical Systems	Device Malfunction	Nationwide
22 Jul 2026Device	CLASS II	Optima XR220amx, Mobile Digital-Ready Radiographic System recalled	GE Medical Systems	Device Malfunction	Nationwide
22 Jul 2026Device	CLASS II	Optima XR200amx, Mobile Digital-Ready Radiographic System recalled	GE Medical Systems	Device Malfunction	Nationwide
8 Jul 2026Device	CLASS II	Medline Convenience Kits: Arterial Line Kit recalled	Medline Industries	Processing Deviation	Nationwide
8 Jul 2026Device	CLASS II	Medline Convenience Kits recalled by Medline Industries	Medline Industries	Processing Deviation	Nationwide
8 Jul 2026Device	CLASS II	Medline Convenience Kits: Imaging Biopsy Tray recalled	Medline Industries	Processing Deviation	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kit: Bhs Neuro DYNJ904900N Medtrx Neuro recalled	Medline Industries	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	Medline convenience kits: Breast Imaging DYNJT5893 Chog recalled	Medline Industries	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	Medtronic O-arm O2 Imaging System recalled by Medtronic Navigation	Medtronic Navigation Inc.-Boxborough	Other	Nationwide
17 Jun 2026Device	CLASS II	Allia IGS 7 Pulse angiographic X-ray system recalled	GE Medical Systems	Other	Nationwide
17 Jun 2026Device	CLASS II	Allia IGS 5 Pulse angiographic X-ray system recalled	GE Medical Systems	Other	Nationwide
17 Jun 2026Device	CLASS II	Allia Moveo angiographic X-ray system recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
17 Jun 2026Device	CLASS II	Allia IGS Pulse angiographic X-ray system recalled by GE Medical Systems	GE Medical Systems	Other	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.