Class II — Philips Medical Systems, Inc.
| Recalling firm | Philips Medical Systems International BV |
|---|---|
| Registered facility | View this company's 54 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Loss of key image functionality due to a bent pedal of the Footswitch. |
| Product | Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper FD2O, 722008 Allura Xper FD2O Biplane, 722010 Allura Xper FD1O, 722011 Allura Xper FD1O/10, 722012 Allura Xper FD2O, 722013 Allura XPER FD2O BIPLANE, 722014 Allura Xper FD1O OR Table, 722015 Allura Xper FD2O OR Table, 722019 Allura Xper FD1O/10 OR Table, 722020 Allura Xper FD2O Biplane OR Table, 722022 Allura Xper FD1O OR Table, 722023 Allura Xper FD2O OR Table, 722024 Allura Xper FD1O/10 OR Table… |
| Quantity | 4180 devices |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to: CZECH REPUBLIC ALBANIA ALGERIA ARGENTINA AUSTRALIA AUSTRIA AZARBAIJAN BAHAMAS BANGLADESH BELGIUM BRAZIL BULGARIA CAYMAN ISLANDS CHILE CHINA COLUMBIA COSTA RICA CROATIA CUBA CZECHOSLOVAKIA DENMARK DOMINICAN REPUB ECUADOR EGYPT ESTONIA FINLAND FRANCE GABON GERMANY GREECE HONG KONG HUNGARY ICELAND INDIA… |
| Initiated | 2014-09-24 |
| Classified | 2016-03-31 |
| Terminated | 2019-03-26 |
| Recall number | Z-1280-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Philips Medical Systems, Inc. (Z-1280-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69339/
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