CLASS II Device recall · Reported 29 Jul 2015 · FDA Enforcement Report
Head Holder shipped with Ingenuity Core 128 Computed recalled
Philips Medical Systems (Cleveland) is recalling Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems, distributed in 32 states. The recall was initiated on 17 Mar 2015 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-2204-2015
- FDA event ID
- 71227
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Mar 2015
- FDA classified
- 22 Jul 2015
- Reported
- 29 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 17 Mar 2015 | Recall initiated by company | |
| 22 Jul 2015 | Classified by FDA | +127 days |
| 29 Jul 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core 128, which was shipped with this system.
Product as listed by the FDA
Head Holder shipped with Ingenuity Core 128 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.
Where it was distributed
Worldwide Distribution-Product was shipped to the following states: AR, AR, AZ, CA, CO, CT, FL, GA, IA, IN, KS, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, WV & WY, and to the following countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, Colombia, Denmark, Ecuador, France, Germany, India, Indonesia, Israel, Japan, Latvia, Libya, Myanmar, Norway, Oman, Poland, Republic of Korea, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom & Viet Nam.
ArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIndianaKansasLouisianaMassachusettsMarylandMichiganMissouriMississippiNorth CarolinaNew JerseyNew MexicoNevada
Questions about this recall
Is Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems recalled?
Yes. Philips Medical Systems (Cleveland) recalled Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems on 17 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-2204-2015.
Why was it recalled?
A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core 128, which was shipped with this system.
Which lots are affected?
Head Holder M/N 4535 671 11331. Ingenuity Core 128 - M/N 728323, Serial #s: 300068, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320017, 320018, 320019, 320020, 320021, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029, 320030, 320031, 320032, 320033, 320034, 320035, 320036, 320037, 320038, 320040, 320041, 320042, 320043, 320044, 320045, 320046, 320047, 320048, 320049, 320050, 320052, 320053, 320054, 320055, 320056, 320057, 320058, 320059 & EP16E110092.
Where was it sold?
Worldwide Distribution-Product was shipped to the following states: AR, AR, AZ, CA, CO, CT, FL, GA, IA, IN, KS, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, WV & WY, and to the following countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, Colombia, Denmark, Ecuador, France, Germany, India, Indonesia, Israel, Japan, Latvia, Libya, Myanmar, Norway, Oman, Poland, Republic of Korea, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom & Viet Nam.
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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