Philips M8000-64100 Table Mount Shipped standard with all IntelliVue Patient Monitors MP40-70, Gas Modules Gl and G5 and

FDA device recall Z-0817-2009 · posted 2009-01-13 · Terminated

Recall details

Recalling firm

Philips Medical Systems

Reason for recall

Table Mounts assembled with incorrect length hardware may fall

Action taken

Philips issued an "Urgent Medical Device Correction" notification to all potentially affected customers on 10/22/08 via UPS for the US customers. The letter mailed to customers outside the US by Philips' regulatory contacts in each country via a tracked method. The letter informs customers of the problem and gives instructions on how to identify affected table mounts. Field Service Engineers will be dispatched to each customer site to inspect each Table Mount. If customers detect any sign of a loose connection between the monitor and the mounting plate while they are awaiting the Field Service Engineer, they are instructed to make sure that the monitor is not in a position to fall. They are asked to disconnect the monitor from the table mount. For additional information, contact Philips Medical Systems at 1-978-687-1501.

Root cause

Process control

Status

Terminated

Product code

DSI

Quantity affected

14,292 units

Distribution

Nationwide Canada Foreign: Argentina, Aruba, Australia, Austria, Bahain, Bangladesh, Belgium, Bosnia, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Egypt, Finland, France, Gabon, G

Date initiated

2008-10-22

Date posted

2009-01-13

Date terminated

2017-03-24

Location

Andover, MA

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