Z-1794-2013Class II

TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum...

Name: Z-1794-2013 TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum...
Creator: Hill-Rom, Inc.
Published: 2013-05-30
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2013-05-30 / Terminated / root cause: design

FDA source

Hill-Rom, Inc. began a recall of TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalCare Bed System is... on 2013-05-30. FDA classified it as Class II and gives the reason as "When the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame, and the mattress foot section will extend away from the bed at an angle. A...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1794-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-30
Posted: 2013-07-23
Terminated: 2014-04-17
Recalling firm: Hill-Rom Inc.
Product: TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
Product code: IOQ Bed, Flotation Therapy, Powered
Reason for recall: When the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame, and the mattress foot section will extend away from the bed at an angle. A patient attempting to get back into the bed may miss the seat and sit on the foot section instead. The patient can slide down to the floor, or fall, with possible injury.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Hill-Rom, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 29, 2013 was sent to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Until the correction is implemented, after placing the bed into chair position, regularly check the foot section of the mattress. If necessary, push it back against the bed frame until the magnets hold it in place before allowing the patient to get back into or out of bed. In addition, forward a copy of this letter to any other facility personnel you deem appropriate. If you have any questions concerning this notification, please contact your distributor, your Hill-Rom representative, or Hill-Rom Technical Support at 800-445-3720 (Mon-Thurs, 8 am-6:30 pm; Friday, 8 am-6 pm).
Quantity in commerce: 4,121 Units
Distribution: Worldwide distribution: USA (nationwide) and countries of: Canada, Colombia, Nigeria, Kuwait and Saudi Arabia.
Product codes and lots: Bed model numbers: PAU001010784, PAU005010784, P1900, PAK169N10184, PAK169N10384, PA8171210184, PA8175210184, PA8175210384, PA8171210384, PA8171310384, and PA8173210384. The AccuMax Quantum VPC, Complete and Convertible mattresses are not serialized, but were distributed between September 2005 and April 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1794-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1794-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-23

Product code IOQ

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)