Ingenia Elition S, Ingenia Elition X
FDA Recall Z-0694-2019 · Posted None
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Recalling FirmPhilips Medical Systems Nederlands
Recall StatusTerminated
Product CodeLNH
Date Initiated2018-12-03
Date Terminated2020-05-12
Product Quantity35
Reason for Recall
During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement.
Firm Action
On December 4, 2018, the firm notified customers of the recall via an Urgent Medical Device Correction letter. The letter informed customers of the product issue.
Customers were asked to do the following:
The user must follow the Instructions for Use to verify that no part of the patient's body, hair, clothing, cables or infusion lines can get trapped or injured by any part of the equipment. Additionally, the VitalScreen shows positioning guidance regarding arm supports and padding.
The user should avoid the use of the yellow Stop Table button on the VitalScreen.
The user must always use the tumble switch or physical Emergency Table Stop button for cases which require the table movement to stop.
Philips stated they would be rolling out FCO78100490 Service Pack 1 for R5.5.0 to affected systems. The Service Pack will remove the "Stop Table" software button on the VitalScreen.
Root Cause
Under Investigation by firm
Distribution Pattern
CA, MN, NJ, NY, OH, TN, TX. Foreign distribution to Canada, Belgium, France, Germany, INdia, Japna, Netherlands, South Africa, Sweden, Switzerland, UAE.
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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