High FDA (Devices)·Z-2303-2012·Announced 2012-09-05

Philips SureSigns VSi and VS2+ Patient Monitors Recalled for Mounting Defect

Philips is recalling SureSigns VSi and VS2+ patient monitors because they may not be properly secured to wall mounts and could fall.

What this means for you

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 involves a risk-of-harm product (falling medical equipment) where injury has not yet been reported, which aligns with the 'High' severity criteria.

Plain-English summary

Philips Healthcare Inc. is recalling the SureSigns VSi and VS2+ patient monitors. The recall involves 2,314 units distributed in the United States and 28 other countries. The affected models are the VSi (part numbers 863275, 863276, 863277) and the VS2+ (part numbers 863278, 863279).

The recall is being issued because the patient monitors may not be properly secured to their wall mounts. This defect creates a risk that the monitors could fall from the wall. The devices are intended for monitoring, recording, and alarming of multiple physiological parameters for adults, pediatrics, and neonates in healthcare environments and during transport within a facility.

Healthcare facilities should identify affected units by checking the serial number ranges CN14800101-CN14801360, CN21201362-CN21202440, CN21202525, SP13701043, and USPP101007. Affected units should be removed from wall mounts and secured to prevent falling until a corrective action is implemented.

The recalled product

Product: Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and
Manufacturer: Philips Healthcare Inc.
Category: Medical Device — Patient Monitor
Hazard: falling-object
impact-injury
Affected units: 2,314

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 (4)

Serial Number Range CN14800101-CN14801360 CN21201362-CN21202440
CN21202525
SP13701043
USPP101007

Distribution

Distributed nationwide across the United States.

Same manufacturer · Philips Healthcare Inc.

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Same hazard · falling object