CLASS II Device recall · Reported 4 Jul 2018 · FDA Enforcement Report
Philips Ingenuity Core recalled by Philips Medical Systems
Philips Medical Systems (Cleveland) is recalling Philips Ingenuity Core 728321, distributed in Hawaii, Kansas, Missouri. The recall was initiated on 28 Mar 2018 and the FDA has classified it as Class II.
Check your package
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-2274-2018
- FDA event ID
- 80176
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Mar 2018
- FDA classified
- 22 Jun 2018
- Reported
- 4 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 28 Mar 2018 | Recall initiated by company | |
| 22 Jun 2018 | Classified by FDA | +86 days |
| 4 Jul 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Philips Ingenuity Core 728321
Where it was distributed
The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.
Questions about this recall
Is Philips Ingenuity Core 728321 recalled?
Yes. Philips Medical Systems (Cleveland) recalled Philips Ingenuity Core 728321 on 28 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-2274-2018.
Why was it recalled?
A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
Which lots are affected?
UDI: (01)00884838059498(21)333169, Serial Number: 333169; UDI: (01)00884838059498(21)310377, Serial Number: 310377; UDI: (01)00884838059498(21)310375, Serial Number: 310375; UDI: (01)00884838059498(21)333171, Serial Number: 333171; UDI: (01)00884838059498(21)333172, Serial Number: 333172
Where was it sold?
The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.
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.
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