Z-2123-2015Class II

GE Healthcare, Precision MPi fluoroscopic imaging systems

Name: Z-2123-2015 GE Healthcare, Precision MPi fluoroscopic imaging systems
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 MPi fluoroscopic imaging systems 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-2123-2015
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 MPi fluoroscopic imaging systems.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2123-2015
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 JAA

K033486Class IIGe Precision MpiNrt-Nordisk Rontgen Teknik A/S / cleared 2003-11-19

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)