CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report

IQon Spectral CT recalled by Philips Medical Systems

Philips Medical Systems (Cleveland) is recalling IQon Spectral CT, distributed nationwide in the US. The recall was initiated on 24 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSystem Serial Number 860004 through 860043, 860046 through 860127, 890002

Quantity recalled25

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2192-2019
FDA event ID: 83365
Recalling firm: Philips Medical Systems (Cleveland), Cleveland, OH
Classification: Class II
Status: Terminated
Recall initiated: 24 Jun 2019
FDA classified: 6 Aug 2019
Reported: 14 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

24 Jun 2019	Recall initiated by company
6 Aug 2019	Classified by FDA	+43 days
14 Aug 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied

Product as listed by the FDA

IQon Spectral CT Model # 728332, computed tomography x-ray system

Where it was distributed

Worldwide distribution. US nationwide including Puerto Rico, Canada, Mexico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Cote D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gibraltar, Greece, Greenland, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malawi, Malaysia, Maldives, Mali, Malta, Martinique, Mauritius, Monaco, Mongolia, Morocco, Mozambique, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, State of Palestine, Panama, Peru, Philippines, Poland, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, and Yemen

Nationwide Georgia Puerto Rico

Questions about this recall

Is IQon Spectral CT recalled?

Yes. Philips Medical Systems (Cleveland) recalled IQon Spectral CT on 24 Jun 2019. The recall is Class II and its status is Terminated. Recall number Z-2192-2019.

Why was it recalled?

Which lots are affected?

System Serial Number 860004 through 860043, 860046 through 860127, 890002

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Philips Medical Systems (Cleveland)

All 315

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Device	CLASS II	Pinnacle Radiation Therapy Planning System recalled	Philips Medical Systems (Cleveland)	Packaging Defects	Nationwide
13 Aug 2025Device	CLASS II	Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System recalled	Philips Medical Systems (Cleveland)	Device Malfunction	Nationwide
21 Sep 2022Device	CLASS II	Pinnacle3 Radiation Therapy Planning System recalled	Philips Medical Systems (Cleveland)	Other	21 states
13 Nov 2019Device	CLASS I	Forte Gamma Camera System is intended to produce images recalled	Philips Medical Systems (Cleveland)	Other	Nationwide
13 Nov 2019Device	CLASS I	Forte Gamma Camera System is intended to produce images recalled	Philips Medical Systems (Cleveland)	Other	Nationwide

Other Imaging Equipment recalls

All 2,336

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