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.
What this means for you
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 is a risk-of-harm medical device with a documented control system malfunction that can cause unexpected movement stops during surgical procedures. No injuries or illnesses have been reported, but the potential for procedural complications and patient safety risks in a surgical setting warrants High severity classification.
Plain-English summary
Getinge Usa Sales Inc is recalling MEERA CL mobile operating tables (Item Number: 700001F0, UDI-DI: 04046768136328) due to a malfunction in the infrared hand control system.
When the table is controlled via the IR-Hand Control, an error code "50037" may occur sporadically, causing the table to stop moving unexpectedly. This can result in procedural delays during surgical interventions, examinations, and treatments.
The MEERA CL tables were distributed worldwide, including in the United States and to Australia, Austria, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, France, Germany, Greece, India, Israel, Japan, Korea, Mexico, Netherlands, New Zealand, Spain, Sweden, Switzerland, Thailand, United Kingdom, and many other countries. Affected facilities should contact the manufacturer for additional information regarding remediation options.
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: 700001F0
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- control-system-failure
- equipment-malfunction
- procedural-delay
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: 04046768136328 S/N: 9
Distribution
Distributed nationwide across the United States.
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