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

Precision RXi 23A/32A Analog System recalled by GE Healthcare

GE Healthcare is recalling Precision RXi 23A/32A Analog System, 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 # 00000001386MC2 00000002109MC7 00000001010MC8 00000001337MC5 00000002212MC9 00000001720MC2 00000001098MC3 00000001454MC8 00000001082MC7 00000001266MC6 00000001656MC8 00000003661MC6

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-2121-2015
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: Other Medical Devices

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 RXi 23A/32A Analog System

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 # 00000001386MC2 00000002109MC7 00000001010MC8 00000001337MC5 00000002212MC9 00000001720MC2 00000001098MC3 00000001454MC8 00000001082MC7 00000001266MC6 00000001656MC8 00000003661MC6

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 Digital system recalled by GE Healthcare	GE Healthcare	Other	Nationwide
29 Jul 2015	CLASS II	Precision MPi fluoroscopic imaging systems recalled by GE Healthcare	GE Healthcare	Other	Nationwide

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