General Electric Med Systems LLC GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976.
Brand
General Electric Med Systems LLC
Lot Codes / Batch Numbers
30920HL3, 30921HL1, 31931HL9, 3457OHL2, 34864HL9, 34911HL8, 35136HL1, 35191HL6, 35244HL3, 35936HL4, 36207HL9, 36361HL4, 36431HL5, 36521HL3, 36702HL9, 36704HL5, 37009HL8, 37261HL5, 37395HL1, 37396HL9, 37597HL2 & 993702WK0
Products Sold
30920HL3, 30921HL1, 31931HL9, 3457OHL2, 34864HL9, 34911HL8, 35136HL1, 35191HL6, 35244HL3, 35936HL4, 36207HL9, 36361HL4, 36431HL5, 36521HL3, 36702HL9, 36704HL5, 37009HL8, 37261HL5, 37395HL1, 37396HL9, 37597HL2 & 993702WK0
General Electric Med Systems LLC is recalling GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 contai due to 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 n. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026