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.
FDA Recall Z-1658-2009 · Posted 2009-09-29
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Recalling FirmNRT - Nordisk Rontgen Teknik A/S
Recall StatusTerminated
Product CodeJAA
Date Initiated2009-05-01
Date Terminated2009-10-20
Product Quantity38 units (US)
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.
Firm 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.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
Nationwide Distribution, including CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OR, PA, TN, VT, WA, WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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