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Recall Observatory FDA recall evidence

Device product

Ingenia Elition S, Ingenia Elition X

Z-0694-2019

December 03, 2018

Class II

Product summary

Firm
Philips Medical Systems Nederlands
Event
Event 81797
Status
Terminated
Classification
Class II
Quantity
35
Official record key
device-enforcement:Z-0694-2019

Official wording

Reason: During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement.

Code information: Software version R5.5.0 Serial numbers: 45027 45011 45010 45024 45032 45026 45054 45035 45051 45052 45007 45043 45044 45031 45039 45025 46001 45033 45050 45034 45049 45037 45048 46004 45046 45008 45058 45028 45029 45030 45042 46005 46011 45040 45045

Distribution pattern: CA, MN, NJ, NY, OH, TN, TX. Foreign distribution to Canada, Belgium, France, Germany, INdia, Japna, Netherlands, South Africa, Sweden, Switzerland, UAE.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement.