CLASS II ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report
Meera CL mobile operating table - Designed recalled by Getinge Usa Sales
Getinge Usa Sales is recalling Meera CL mobile operating table - Designed for the placement and positioning of the, distributed nationwide in the US. The recall was initiated on 3 Oct 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0462-2025
- FDA event ID
- 95498
- Recalling firm
- Getinge Usa Sales, Wayne, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Oct 2024
- FDA classified
- 14 Nov 2024
- Reported
- 20 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 3 Oct 2024 | Recall initiated by company | |
| 14 Nov 2024 | Classified by FDA | +42 days |
| 20 Nov 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bhutan, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, India, Israel, Japan, Jordan, Korea, Republic Of Kuwait, "Macedonia, The Former Yugoslav Republic Of", Malaysia, Mauritius, Mexico, Montenegro, Netherlands, New Zealand, Panama, Peru, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam.
Questions about this recall
Why was it 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
Which lots are affected?
UDI-DI: 04046768136786 S/N: 491 - 603
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bhutan, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, India, Israel, Japan, Jordan, Korea, Republic Of Kuwait, "Macedonia, The Former Yugoslav Republic Of", Malaysia, Mauritius, Mexico, Montenegro, Netherlands, New Zealand, Panama, Peru, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 95498| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Meera CL mobile operating table - Designed recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide | |
| CLASS II | Meera CL mobile operating table - Designed recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide | |
| CLASS II | Meera CL mobile operating table - Designed recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide | |
| CLASS II | Meera CL mobile operating table - Designed recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide | |
| CLASS II | Meera CL mobile operating table - Designed recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide | |
| CLASS II | Meera CL mobile operating table - Designed recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide | |
| CLASS II | Meera CL mobile operating table - Designed recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide |
More recalls from Getinge Usa Sales
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Vaporizer Sevoflurane, Quik-Fil recalled by Getinge Usa Sales | Getinge Usa Sales | Other | CT, KY |
| Device | CLASS II | Meera CL mobile operating table - Designed recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide |
| Device | CLASS II | Meera CL mobile operating table - Designed recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide |
| Device | CLASS II | Meera CL mobile operating table - Designed recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide |
| Device | CLASS II | Meera CL mobile operating table - Designed recalled by Getinge Usa Sales | Getinge Usa Sales | Other | Nationwide |
Other Surgical Instruments recalls
All 3,891| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |