Reported Jan 24, 2024 · Ongoing

Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 -…

Getinge USA Sales Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Getinge Usa Sales Inc · 1 Geoffrey Way · Wayne, NJ · 07470-2035

Is this the product you have?

  • Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 30 - ARD569015131C, BLUE 30 - ARD569025111C, BLUE 30 - ARD569025131C, BLUE 30 - ARD569035111C, BLUE 30 - ARD569035131C, BLUE 30 - ARD569045111C, BLUE 30 - ARD569045131C, BLUE 30 - ARD569055111C, BLUE 30 - ARD569055131C, BLUE 30 - ARD569065112C, BLUE 30 - ARD569065132C, BLUE 30 C - ARDBLU209000C, BLUE 3030 - ARD569015411C, BLUE 3030 - ARD569015431C, BLUE 80 - ARD569014111A, BLUE 80 - ARD569014111C, BLUE 80 - ARD569014131C, BLUE 80 - ARD569064112C, BLUE 80 - ARD569064132C, BLUE 8030 - ARD569014411C, BLUE 8030 - ARD569014431C, BLUE 8080 - ARD569014211C, BLUE 8080 - ARD569014231C, BLUE 30 - ARD569065113C, BLUE 30 - ARD569065123C, BLUE 30 - ARD569075113A, BLUE 30 - ARD569075113C, BLUE 30 - ARD569075123C, BLUE 80 - ARD569064113C, BLUE 80 - ARD569064123C, BLUE 80 - ARD569074113A, BLUE 80 - ARD569074113C, BLUE 80 - ARD569074123C, HLX BLUE 3 - ARD569132113A
Lot codes and dates
  • All systems affected
Amount recalled
236793 units in total

This recall covers 15 products

The agency filed one notice per product. You are reading one of them; the other 14 are below.

2 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

A potential for a light system to fall in the operating room.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.