Z-2121-2015Class II

GE Healthcare Precision RXi 23A/32A Analog System

Name: Z-2121-2015 GE Healthcare Precision RXi 23A/32A Analog System
Creator: GE Healthcare
Published: 2015-06-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2015-06-12 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare began a recall of GE Healthcare Precision RXi 23A/32A Analog System on 2015-06-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2121-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-12
Posted: 2015-07-20
Terminated: 2017-08-03
Recalling firm: GE Healthcare
Product: GE Healthcare Precision RXi 23A/32A Analog System
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: GE Healthcare sent an "Urgent Medical Device Correction" letter dated June 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Perform a visual check before and after each use for the presence of the four (4) mounting screws as shown in the pictures below. Check the secureness of these screws by hand. If these screws are present and secure, you may continue use of the system. If any of these screws are missing or can easily be turned by hand, follow the precautions below before you continue use with the monitor(s). 1. Position the monitor suspension in the most frequently used position and limit further movement as much as possible. 2. Clearly inform (e.g. through signage and verbal instructions) the users and other auxiliary personnel who may come in contact with the system to not move the monitor suspension once in position. 3. Contact your GE Healthcare representative to inform them of any loose or missing screws. For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 788 (701 US; 87 OUS)
Distribution: 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.
Product codes and lots: Mfg Lot or Serial # 00000001386MC2 00000002109MC7 00000001010MC8 00000001337MC5 00000002212MC9 00000001720MC2 00000001098MC3 00000001454MC8 00000001082MC7 00000001266MC6 00000001656MC8 00000003661MC6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2121-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2120-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2121-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2122-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20
Z-2123-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-20

Product code OWB

K082243Class IIPrecision Rxi Analog and Digital X-Ray SystemsGeneral Medical Merate S.P.A / cleared 2008-11-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)