Z-2605-2016Class II

Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating...

Name: Z-2605-2016 Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating...
Creator: American National Mfg Inc
Published: 2016-07-11
License: https://open.fda.gov/license/

Agiliti Health - Corona / initiated 2016-07-11 / Terminated / root cause: software

FDA source

American National Mfg Inc began a recall of Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress on 2016-07-11. FDA classified it as Class II and gives the reason as "The Panacea Air Pro Mattress Control Unit is being recalled due to a firmware problem, which may result in the device not having the firmness range required". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2605-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-11
Posted: 2016-08-19
Terminated: 2017-01-17
Recalling firm: Agiliti Health - Corona
Product: Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.
Product code: FNM Mattress, Air Flotation, Alternating Pressure
Reason for recall: The Panacea Air Pro Mattress Control Unit is being recalled due to a firmware problem, which may result in the device not having the firmness range required.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: An Urgent Medical Device Recall letter, dated 7/11/16, was sent to customers to inform them of a recall involving the Panacea Air Pro Mattress Control Unit also labeled as Platinum 5000, US Model Number 5000, Serial numbers 9500051 through 9500300. The letter informs the customers that the recall has been identified due to firmware problem. The letter informs the customers of the problem identified and the actions to be taken. Customers were asked to immediately examine their inventory and quarantine the affected device. A shipping label would be provided for return and update of the affected devices. All customers that the device was further distributed to would need to be notified of the recall.
Quantity in commerce: 31 units
Distribution: Distributed to the US -- WI, OH, IL, TX, AZ, MD, IA, PA, CO, WA, ID, MN, LA, WY, and MS.
Product codes and lots: Serial No. 9500051 sequential to 9500300.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2605-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2605-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19

Product code FNM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)