FDA (Devices) recall action 95498

Getinge Usa Sales Inc recalled 8 products on 2024-11-20

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2024-11-20
Critical: 0
Units: 878

Why these products were recalled

Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the MEERA-table is controlled via an IR-Hand Control and may result in procedural delay

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

ModerateFDA (Devices)··2024-11-20
Getinge MEERA CL Mobile Operating Table Recalled for Intermittent Movement Errors
Getinge is recalling 52 MEERA CL mobile operating tables because an error code may cause the table to stop moving, potentially delaying surgical procedures.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F2
Category
Distribution
0 states
HighFDA (Devices)··2024-11-20
MEERA CL Operating Table Error Code 50037 Causes Unexpected Stoppage
The MEERA CL operating table may experience error code 50037, causing the table to unexpectedly stop during operation. This error occurs sporadically when controlled via an IR-Hand Control and may delay surgical procedures.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001B0
Category
Distribution
0 states
ModerateFDA (Devices)··2024-11-20
Getinge MEERA CL mobile operating table recalled for sporadic movement errors
Getinge is recalling 234 MEERA CL mobile operating tables because an error code may cause the table to stop moving sporadically, potentially delaying surgical procedures.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001B2
Category
Distribution
0 states
HighFDA (Devices)··2024-11-20
Operating Table May Stop Unexpectedly During Surgery Due to Control Error
MEERA CL mobile operating tables may experience an error code that causes the table to stop moving unexpectedly during surgery, resulting in procedural delays.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001F0
Category
Distribution
0 states
HighFDA (Devices)··2024-11-20
MEERA CL Mobile Operating Table Control Malfunction Recall
The MEERA CL mobile operating table may experience error code 50037 that stops table movement during use, causing surgical procedure delays. Getinge recalled 342 units distributed worldwide.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment, Item Number: 720001B0
Category
Distribution
0 states
ModerateFDA (Devices)··2024-11-20
FDA Recalls MEERA CL Mobile Operating Tables for Unintended Movement Stops
Getinge Usa Sales Inc is recalling 112 MEERA CL mobile operating tables because error code 50037 may cause the table to stop moving unexpectedly when controlled via IR hand control, resulting in procedural delays.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B0
Category
Distribution
0 states
HighFDA (Devices)··2024-11-20
MEERA CL operating table stops responding during surgery when IR-Hand Control errors occur
The MEERA CL surgical operating table may fail to respond when error code 50037 occurs on its IR-Hand Control, causing the table to stop moving during procedures and resulting in procedural delays.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F0
Category
Distribution
0 states
HighFDA (Devices)··2024-11-20
MEERA CL operating table may stop unexpectedly during surgical procedures
The MEERA CL operating table may experience error code 50037 on its IR-Hand Control, causing the table to stop mid-procedure. No injuries have been reported.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B2
Category
Distribution
0 states