The Recall Desk
HighFDA (Devices)·Z-0348-2016·Announced 2015-12-09

Philips INTEGRIS Cardio System Ceiling Suspension Recall

Philips is recalling eight INTEGRIS cardio systems because the ceiling suspension system may 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 equipment) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Philips Medical Systems, Inc. is recalling eight units of the INTEGRIS cardio system, model 722121. The recall is due to a defect where the monitor ceiling suspension system may fall.

The affected units were distributed worldwide, including in the United States, Canada, Australia, and several other countries. The specific serial numbers for the recalled units are 1656, 1667, 1687, 1668, 1669, 1670, 1671, and 1685.

Hospitals and healthcare facilities should contact Philips Medical Systems for instructions on how to address the defect and ensure the safety of the equipment.

The recalled product

Product
Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and th
Affected units
8

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 (1)

  • S/N: 1656 1667 1687 1668 1669 1670 1671 1685

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Philips Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →