CLASS II Device recall · Reported 29 Jul 2015 · FDA Enforcement Report

Precision MPi fluoroscopic imaging systems recalled by GE Healthcare

GE Healthcare is recalling Precision MPi fluoroscopic imaging systems, distributed nationwide in the US. The recall was initiated on 12 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMfg Lot or Serial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

Quantity recalled788 (701 US; 87 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2123-2015
FDA event ID: 71574
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 12 Jun 2015
FDA classified: 20 Jul 2015
Reported: 29 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

12 Jun 2015	Recall initiated by company
20 Jul 2015	Classified by FDA	+38 days
29 Jul 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. Recall affects the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system, Precision RXi 23A/32A Analog System, Precision RXi Digital system and Precision MPi fluoroscopic imaging systems.

Product as listed by the FDA

GE Healthcare, Precision MPi fluoroscopic imaging systems.

Where it was distributed

Worldwide Distribution - US Nationwide Distribution including GU and DC., and to the countries of : Australia, Bulgaria, Canada, Chile, Dominican Republic, Germany, Ireland, Italy, Kuwait, Lebanon, Portugal, Romania, Russia, Saudi Arabia, Slovakia, Spain, Taiwan,Turkey, United Kingdom, Venezuela and Yemen.

Nationwide District of Columbia

Questions about this recall

Why was it recalled?

Which lots are affected?

Mfg Lot or Serial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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 71574

This product is part of a recall event; the main page for the event is Precision 500D Classical R & F system recalled by GE Healthcare.

Reported	Class	Recall	Company	Reason	Where
29 Jul 2015	CLASS II	Precision 500D Classical R & F system recalled by GE Healthcare	GE Healthcare	Other	Nationwide
29 Jul 2015	CLASS II	Precision RXi 23A/32A Analog System recalled by GE Healthcare	GE Healthcare	Other	Nationwide
29 Jul 2015	CLASS II	Precision RXi Digital system recalled by GE Healthcare	GE Healthcare	Other	Nationwide

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