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 | IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends. |
| Product | IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352 |
| Quantity | 42,600 |
| Distribution | United States: Nationwide Foreign Countries: Germany, Austria, Finland, Sweden, Australia, Qatar, Canada, Netherlands, New Zealand, Portugal, United Kingdom, Spain, Belgium, France, Switzerland, Norway, Czech Republic, Poland, Italy, Singapore, Denmark, Iceland, India, Saudi Arabia, Ireland, Oman, Bahrain, Japan, Israel, Malaysia, South Africa, Turkey, Thailand, Latvia, Bulgaria, Indonesia, S… |
| Initiated | 2014-05-22 |
| Classified | 2014-06-10 |
| Terminated | 2018-05-16 |
| Recall number | Z-1746-2014 |
| 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-1746-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68349/
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