Recall Z-1472-2026 ยท FNM Mattress, Air Flotation, Alternating Pressure
Agiliti Health - Ellis
Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure
| Date | Feb 26, 2026 (initiated Jan 21, 2026) |
| Status | Open, Classified |
| Reason | Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after using the Autofirm function for 10 minutes. This issue only occurs when the 10-minute timer is allowed to elapse after the Autofirm button is pressed after initial setup, and it only affects the Microclimate Management function. |
| Root cause | Software design |
| Action | The firm issued an URGENT: Medical Device Correction notice to its consignees on 01/21/2026 via email. The notice explained the issue with the device, potential risk, how to recognize the failure, and requested the following: "Actions to be Taken by Customer 1. Immediately share this Notice with all necessary parties within your organization. 2. Examine the stock in your organization to determine if you have any of the devices in your organization. a. If any devices have been transferred to another organization, please forward a copy of this Advisory Notice and the attached Customer Respon |
| Quantity | 4286 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.