FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
- Recall number
- Z-0306-2019
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
- Status
- Terminated
- Initiated
- 2017-06-07
- Posted
- not on file
- Terminated
- 2019-07-03
- Reason
- It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
- Root cause
- Software design
- Action
- The recalling firm sent Customer Information letters dated June 7, 2017, to affected customers. The letter notified customers of the product issue. Customers were instructed to determine whether they had a potentially affected system by checking the software version of their device. Customers were reminded that the "Impressions" section of the report is not intended for diagnostic use. Users should instead focus on the total calcium score shown in the "Findings" section, the coronary artery score(s) and/or the "Age and Gender" graph as identified in the Instructions for Use (IFU). The firm sent a follow-up dated July 3, 2018, to inform customers that software updates had been released which resolved the issue. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America and Canada, contact the Customer Care Solutions Center (1 -800-722-9377 and follow the prompts).
- Quantity
- 64
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- software versions 4.7.0 or 4.7.2
- 510(k) numbers
- ["K171850"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28