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SmartLinx Vitals Plus
Philips North America LLC · Model SL-VP-BPAP-HW · UDI-DI 03615040001329
MWI
Prescription
10
510(k) clearances
2,065
Adverse events (45 deaths)
85
Recalls
172
Facilities
Description
Vitals Plus NiBP Suntech Thermometer Filac
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-21 | Midmark Corporation | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
| 2026-08-21 | Midmark Corporation | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
| 2026-08-21 | Midmark Corporation | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
| 2026-08-21 | Midmark Corporation | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and |
| 2026-07-20 | GE Medical Systems Information Technologies Inc | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and |
| 2026-07-10 | GE Medical Systems Information Technologies Inc | Portrait Core Services Software version V1.2.0 Security Vulnerability |
| 2026-01-30 | Covidien LLC | Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring s |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.