Philips Medical Systems, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0348-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures

Product Classification:

Class II

Date Initiated: February 3, 2015

Date Posted: December 9, 2015

Recall Number: Z-0348-2016

Event ID: 70370

Reason for Recall:

Monitor Ceiling Suspension system may fall

Status: Terminated

Product Quantity: 8 units

Code Information:

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

Distribution Pattern:

Worldwide Distribution - US Nationwide and the countries of: Canada,Australia, Austria, Brazil, Chile, China, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, South Africa, Spain, Switzerland and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated