Philips SureSigns VS4 Vital Signs Monitor — Class II medical device recall Z-2894-2018
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-2894-2018 |
|---|---|
| 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 | 00884838087095 |
Product
Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 monitor is for monitoring, recording, and alarming of multiple physiological parameters in healthcare environments for the patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.
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-2894-2018. 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.