Agency classClass IIOur severity:High FDA (Devices)·Z-0824-2013·Announced 2013-02-20

Philips SureSigns VS2+ Vital Signs Monitor Recall for Screen Lockup

Philips Healthcare is recalling 3,248 SureSigns VS2+ monitors because the screen may lock up and stop monitoring patients.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device failing to monitor patients, which poses a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Philips Healthcare Inc. is recalling 3,248 units of the SureSigns VS2+ vital signs monitor, including models 863278 and 863279. These devices are used in healthcare environments to monitor, record, and alarm for multiple physiological parameters in adults, pediatrics, and neonates, as well as during transport within a healthcare facility.

The recall is being issued because the device screen may lock up and stop monitoring during patient use. This malfunction could result in the loss of vital sign data and alarms, potentially compromising patient safety. The affected units were distributed worldwide, including across the United States and numerous international markets.

Healthcare facilities should check their inventory for the specific serial numbers listed in the official recall notice. If a device is affected, it should be removed from service and returned to Philips Healthcare for repair or replacement according to the company's instructions.

The recalled product

Product: Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults…
Manufacturer: Philips Healthcare Inc.
Category: Medical Device — Vital Signs Monitor
Hazard: device-malfunction
loss-of-monitoring
Affected units: 3,248

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Serial Numbers: CN14800428
CN14800429
CN14800430
CN14800431
CN14800432
CN14800433
CN14800434
CN14800435
CN14800436
CN14800437
CN14800438
CN14800439
CN14800440
CN14800756
CN14800763
CN14800764
CN14800765
CN14800772
CN14800773
CN14800822

Distribution

Distributed nationwide across the United States.

Same manufacturer · Philips Healthcare Inc.

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