FDA Medical Device Recalls (openFDA)
Philips Medical Systems Nederlands: Ingenia Elition S, Ingenia Elition X
- Recall number
- Z-0694-2019
- Recalling firm
- Philips Medical Systems Nederlands
- Product
- Ingenia Elition S, Ingenia Elition X
- Status
- Terminated
- Initiated
- 2018-12-03
- Posted
- not on file
- Terminated
- 2020-05-12
- Reason
- During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement.
- Root cause
- Under Investigation by 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.
- Quantity
- 35
- Distribution
- CA, MN, NJ, NY, OH, TN, TX. Foreign distribution to Canada, Belgium, France, Germany, INdia, Japna, Netherlands, South Africa, Sweden, Switzerland, UAE.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K173356"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 3002807880
- Firm city
- Best
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28