Philips SureSigns VM 3/4/6/8 Patient Monitors — Class II medical device recall Z-2895-2018
Ongoing recall by Philips Electronics North America Corporation, reported 2018-08-29, distributed nationwide. Philips has received several reports in which monitors with lithium ion batteries that had exceeded their batt
| Recall number | Z-2895-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2018-07-13 |
| Classified | 2018-08-22 |
| Reported by FDA | 2018-08-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DO, EE, EG, ES, FI, FR, GB, GH, HK, HR, HU, ID, IL, IN, IR, IS, IT, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MT, MX, MY, NI, NL, NO, NP, NZ, OM, PE, PH, PK, PL, PT, QA, RO, SA, SE, SG, SK, SV, TH, TR, TT, TW, VE, VN, ZA |
| Reason classes | labeling, device malfunction |
| UPC / GTIN / UDI-DI | 00884838000032, 00884838000049, 00884838000056, 00884838000063, 00884838000087, 00884838028791, 00884838028807, 00884838028814, 00884838028821, 00884838028838, 00884838050464 |
Product
Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The SureSigns VM4, VM6, and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: " ECG " Respiration " NBP " S2pO " IBP " CO2 " Temperature
Reason for recall
Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.
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-2895-2018. 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.