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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall involves a documented software malfunction that causes the operating table to stop unexpectedly. No injuries or hospitalizations have been reported, but the defect poses a risk of harm during surgical procedures. Per FDA severity criteria, this qualifies as High (Score 3) as a risk-of-harm medical device where injury has not yet been reported.
Plain-English summary
Getinge Usa Sales Inc is recalling 112 units of the MEERA CL mobile operating table, Item Number 700001B0. The MEERA CL is a surgical device designed for patient positioning before, during, and after surgical procedures, as well as for examination and treatment.
The device may generate error code 50037 on the IR-Hand Control when the table is being controlled. When this error occurs, the table stops moving. This error may occur sporadically and can result in procedural delays.
The affected units have been distributed worldwide, including across the United States and to countries including Australia, Austria, Brazil, Canada, France, Germany, India, Japan, Mexico, New Zealand, Spain, Switzerland, United Kingdom, and others. The device carries UDI-DI 04046768136786 with serial numbers 491-603.
Healthcare facilities using the MEERA CL operating table should be aware of this potential malfunction. If error code 50037 occurs, the table will stop movement. Facilities should contact Getinge Usa Sales Inc regarding this issue and any available corrective actions or firmware updates.
The recalled product
- 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
- Manufacturer
- Getinge Usa Sales Inc
- Affected units
- 112
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04046768136786 S/N: 491 - 603
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Getinge Usa Sales Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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