FDA Medical Device Recalls (openFDA)
NRT - Nordisk Rontgen Teknik A/S: 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.
- Recall number
- Z-1658-2009
- Recalling firm
- NRT - Nordisk Rontgen Teknik 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.
- Status
- Terminated
- Initiated
- 2009-05-01
- Posted
- 2009-09-29
- Terminated
- 2009-10-20
- Reason
- 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.
- 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
- 38 units (US)
- Distribution
- Nationwide Distribution, including CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OR, PA, TN, VT, WA, WI.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K033486"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 1000188474
- Firm city
- Hasselager
- Firm state
- not on file
- Firm country
- Denmark
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28