Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable… — Class II medical device recall Z-1067-2019
Terminated recall by Philips North America, LLC, reported 2019-04-03, distributed nationwide. Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturing defect that
| Recall number | Z-1067-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2019-01-25 |
| Classified | 2019-03-28 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2020-04-21 |
| Distributed | Nationwide (US) |
| Quantity | 40 |
| Lot numbers | 2018-28 |
| Model numbers | 989803176201 |
Product
Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX40 is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center, the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center. The MX40 can provide time-limited local monitoring when it is not connected to the wireless network.
Reason for recall
Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturing defect that may affect the operation of the monitor
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1067-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.