Ingenia Elition S, Ingenia Elition X
This recall has been terminated (originally issued December 3, 2018).
- Recall Initiated
- December 3, 2018
- Terminated
- May 12, 2020
- Recall Number
- Z-0694-2019
- Quantity
- 35
- Official Source
- View on FDA website ↗
Reason for Recall
During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement.
Distribution
CA, MN, NJ, NY, OH, TN, TX. Foreign distribution to Canada, Belgium, France, Germany, INdia, Japna, Netherlands, South Africa, Sweden, Switzerland, UAE.
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
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.