FDA Device recall Z-2204-2015
Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems
- FDA Device
- Class II
- terminated
- Published 2015-07-29
On 2015-07-29 the FDA classified a Class II recall of Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems by Philips Medical Systems Cleveland, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2204-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-17 |
| Published | 2015-07-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | 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 |
Product
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.
Reason
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.
Identifiers
| code_info | Head Holder M/N 4535 671 11331. Ingenuity Core 128 - M/N 728323, Serial #s: 300068, 320003, 320004, 320005, 320006, 320…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2204-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.