Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported November 23, 2016
Ingenuity Core 128 Computed Tomography X-ray system, Model 728323
The product label does not include the correct current rating.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Medical Systems (Cleveland) Inc recalled Ingenuity Core 128 Computed Tomography X-ray system, Model 728323 - a low-severity action.
Ingenuity Core 128 Computed Tomography X-ray system, Model 728323 was recalled by Philips Medical Systems (Cleveland) Inc in November 23, 2016. Reason: The product label does not include the correct current rating.. Check the official notice for the remedy. Verify recall #Z-0596-2017 with the FDA Devices before acting.
The recall
Philips Medical Systems (Cleveland) Inc issued this low-severity FDA Devices recall-The product label does not include the correct current rating..
- Low
- severity level
- 15 units
- affected scope
- Class III
- classification
- November 23, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0596-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0596-2017) was formally reported on November 23, 2016, with the manufacturer initiating the action on October 13, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Philips Medical Systems (Cleveland) Inc is listed as the recalling firm, operating out of Cleveland, OH. Federal records list the affected scope as 15.
The documented reason for this recall is: The product label does not include the correct current rating. Distribution data in the federal record shows the product reached: Worldwide distribution. The products were shipped to the following states: AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, PA, SC, TX, and UT. There are five (5) government accounts for this recall: DEPARTMENT OF VETERA…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
15
Related Recalls
6
3 from same agency
Product description
Ingenuity Core 128 Computed Tomography X-ray system, Model 728323
Reason for recall
The product label does not include the correct current rating.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0596-2017 |
| Date reported | November 23, 2016 |
| Date initiated | October 13, 2016 |
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
| Firm location | Cleveland, OH |
| Affected scope | 15 |
| Distribution | Worldwide distribution. The products were shipped to the following states: AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, PA, SC, TX, and UT. There are five (5) government accounts for this recall: DEPARTMENT OF VETERANS AF, VETERANS WAY … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0596-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Ingenuity Core 128 Computed Tomography X-ray system, Model 728323. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 15.
Why was this product recalled? ▼
The product label does not include the correct current rating.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2016. Severity: Low. Recall number: Z-0596-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. The products were shipped to the following states: AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, PA, SC, TX, and UT. There are five (5) government accounts for this recall: DEPARTMENT OF VETERANS AF, VETERANS WAY AND LAMONT ST, Mountain Home, TN 37684; US ARMY EVANS COMMUNITY H, 1650 Cochrane Cir, Colorado Springs, CO 80913; US VETERANS ADMINISTRATION, 3710 SW US VETERANS HOSPITAL, PORTLAND, OR 97239; VA MEDICAL CENTER, 4100 W 3RD ST, DAYTON, OH 45428; VAMC - PHILADELPHIA, UNIVERSITY & WOODLAND AVE, PHILADELPHIA, PA 19104. There are five (5) Canadian accounts for this recall: FIVE HILLS HEALTH REGION, 55 DIEFENBAKER DR, MOOSE JAW, SASKATCHEWAN S6J 0C2; INSTITUT UNIV CARDIOLOGIE, 2725 CH STE FOY, SAINTE FOY, QUEBEC G1V 4G5; LAKERIDGE HEALTH, 1 HOSPITAL CRT, OSHAWA, ONTARIO L1G 2B9; LAKERIDGE HEALTH BOWMANVI, 47 LIBERTY ST S, BOWMANVILLE, ONTARIO L1C 2N4; MCGILL UNIVERSITY HEALTH, 1051 BOUL D¿CARIE, MONTR¿AL, QUEBEC H4A 0A5. There were zero (0) Mexican accounts for this recall. The recalled products were shipped to the following countries: Argentina, Australia, Belgium, China, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0596-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 23, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.