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Terminated

GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976.

FDA Recall Z-1087-2007 · Posted 2007-09-25

Recalling FirmGeneral Electric Med Systems LLC
Recall StatusTerminated
Product CodeKPR
Date Initiated2006-05-31
Date Terminated2007-12-11
Product Quantity22 units

Reason for Recall

Labeling; failure to properly label per 21 CFR 1010.2 and 1010.3 -The Operator Console of the Proteus XR/a General Purpose Radiographic Systems were not properly labeled.

Firm Action

Consignees were notified of the problem by a visit. To address the Proteus System shipped to the field, a Field Modification (FMI) was created to correct units in the field.

Root Cause

Other

Distribution Pattern

Nationwide; including states of WA,KS, CO, NM, NC, FL, MT, AZ, TX, IL, NY, MD, and GA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993090SILHOUETTE FCGe Medical Systems, Inc. · 1999-10-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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