Z-1658-2009

Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray system, intended for a...

Name: Z-1658-2009 Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray system, intended for a...
Creator: NRT - Nordisk Rontgen Teknik A/S
Published: 2009-05-01
License: https://open.fda.gov/license/

NRT X-Ray a/S / initiated 2009-05-01 / Terminated

FDA source

NRT - Nordisk Rontgen Teknik A/S began a recall of Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including... on 2009-05-01. The reason FDA records is "The GE Precision MPi is in violation with 21 CFR Part 1020.32 requiring a signal audible to the fluoroscopist to sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1658-2009
Status: Terminated
Initiated: 2009-05-01
Posted: 2009-09-29
Terminated: 2009-10-20
Recalling firm: NRT X-Ray a/S
Product: Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: The GE Precision MPi is in violation with 21 CFR Part 1020.32 requiring a signal audible to the fluoroscopist to sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure.
FDA root cause: Radiation Control for Health and Safety Act
Action: An Advisory Notice concerning GE Precision MPi, dated May 1, 2009, was issued to Healthcare Professionals. The notice discussed the problem, risk, recommended immediate action, future actio, and affected system and serial numbers. A GE Field Service Representative will visit each affected U.S. customer site and introduce a speaker connected to the generator touch screen (to which the audible tone is delivered) in the operator's room, to be placed on the wall in the x-ray room. For further information, customers were to contact their local GE field engineer.
Quantity in commerce: 38 units (US)
Distribution: Nationwide Distribution, including CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OR, PA, TN, VT, WA, WI.
Product codes and lots: Serial Numbers: 507003, 507004, 507005, 510004, 510009, 510010, 513001, 513003, 513007, 518001, 518002, 518004, 518005, 518006, 518011, 518013, 518014, 518015, 518017, 518018, 518020, 522001, 522002, 522003, 522004, 522005, 522006, 522008, 522009, 522012, 522014, 522015, 522016, 522018, 522019, 536001, 536002, 536003, 536006 and 536007.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)