Z-1921-2017Class II

ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single...

Name: Z-1921-2017 ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single...
Creator: Roho Inc.
Published: 2017-03-20
License: https://open.fda.gov/license/

ROHO, Inc. / initiated 2017-03-20 / Terminated / root cause: manufacturing process

FDA source

Roho Inc. began a recall of ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology on 2017-03-20. FDA classified it as Class II and gives the reason as "When the Smart Check tool is used to perform a Smart Setup with one of the affected cushions, it may adversely affect the setup process resulting in an improper cushion setup. Sitting on an over inflated or under...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1921-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-20
Posted: 2017-04-05
Terminated: 2019-05-10
Recalling firm: ROHO, Inc.
Product: ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.
Product code: KIC Cushion, Flotation
Reason for recall: When the Smart Check tool is used to perform a Smart Setup with one of the affected cushions, it may adversely affect the setup process resulting in an improper cushion setup. Sitting on an over inflated or under inflated Sensor Ready Cushion may reduce or eliminate the benefits provided by the cushion, increasing the risk to skin or to other soft tissue.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: On 3/13/17, firm began notifying customers of recall via emailed or mailed letter. The notification sent to dealers and distributors includes a request to forward the communication to their customer and send an acknowledgement back once all of their customers have received a copy of the communication. Customers (product users) will not be required to send the product they are using back. Instead, the recall letter provided two options: 1) keep the cushion and follow additional set-up instructions provided within the letter that would mitigate the risk or 2) contact the supplier to have the cushion replaced. Product that had been in use and is replaced will be destroyed (evidence to be provided to ROHO, Inc. if destroyed by a customer). Unused product that is still in stock with the firm will be destroyed.
Quantity in commerce: 5646 units
Distribution: Nationwide, Sweden, Germany, New Zealand, Finland, Australia, Singapore, Korea, Luxembourg, Czech Republic, South Africa, Canada, Switzerland, United Arab Emirates, Spain, Austria, Hong Kong, Iceland, Japan, Canada, Italy, Ireland, France, United Kingdom
Product codes and lots: Serial Numbers: A2920163 through A3185287 Model Numbers: 1R1010H-CA-SC, 1R109M-CA-SR, 1R1211H-CH-SR, 1R88H-CA-SR, 1R1010H-CA-SCDM, 1R109M-CF-SR, 1R1212H-CA-SR, 1R88H-CF-SR, 1R1010H-CA-SR, 1R109M-CH-SR, 1R1212H-CH-SR, 1R88H-CH-SR, 1R1010H-CF-SCDM, 1R1110H-CA-SC, 1R129H-CA-SR, 1R88M-CA-SR, 1R1010H-CF-SR, 1R1110H-CA-SR, 1R1310H-CA-SR, 1R88M-CF-SR, 1R1010H-CH-SR, 1R1110H-CF-SR, 1R1310H-CF-SR, 1R89H-CA-SR, 1R1010M-CA-SC, 1R1110H-CH-SC, 1R1311H-CA-SR, 1R89H-CF-SR, 1R1010M-CA-SCDM, 1R1110H-CH-SR, 1R1311H-CH-SR, 1R89M-CA-SR, 1R1010M-CA-SR, 1R1110M-CA-SR, 1R1411H-CA-SR, 1R89M-CF-SR, 1R1010M-CF-SCDM, 1R1110M-CF-SR, 1R1411H-CF-SR, 1R910H-CA-SR, 1R1010M-CF-SR, 1R1110M-CH-SC, 1R1511H-CA-SR, 1R910H-CF-SR, 1R1010M-CH-SR, 1R1110M-CH-SR, 1R66H-CA-SR, 1R910H-CH-SC, 1R1011H-CA-SC, 1R1111H-CA-SC, 1R66H-CF-SR, 1R910H-CH-SR, 1R1011H-CA-SR, 1R1111H-CA-SR, 1R67H-CF-SR, 1R910M-CA-SR, 1R1011H-CF-SR, 1R1111H-CF-SR, 1R77H-CA-SR, 1R910M-CF-SR, 1R1011H-CH-SC, 1R1111H-CH-SC, 1R77H-CF-SR, 1R911H-CA-SC, 1R1011H-CH-SR, 1R1111H-CH-SR, 1R77M-CA-SR, 1R911H-CA-SR, 1R1011M-CA-SC, 1R1111M-CA-SR, 1R77M-CF-SR, 1R911H-CF-SR, 1R1011M-CA-SR, 1R1111M-CF-SR, 1R78H-CA-SR, 1R911H-CH-SR, 1R1011M-CF-SR, 1R1111M-CH-SR, 1R78H-CF-SR, 1R98H-CA-SR, 1R1012H-CA-SR, 1R1112H-CA-SR, 1R78M-CA-SR, 1R98H-CF-SR, 1R1012H-CF-SR, 1R1112H-CF-SR, 1R78M-CF-SR, 1R99H-CA-SC, 1R1012H-CH-SR, 1R1112H-CH-SR, 1R79H-CA-SR, 1R99H-CA-SCDM, 1R108H-CA-SR, 1R119H-CA-SC, 1R79H-CF-SR, 1R99H-CA-SR, 1R108H-CF-SR, 1R119H-CA-SR, 1R810H-CA-SR, 1R99H-CF-SCDM, 1R109H-CA-SCDM, 1R119H-CF-SR, 1R810H-CF-SR, 1R99H-CF-SR, 1R109H-CA-SR, 1R1210H-CA-SC, 1R810M-CA-SR, 1R99H-CH-SR, 1R109H-CF-SCDM, 1R1210H-CA-SR, 1R87H-CA-SC, 1R99M-CA-SR, 1R109H-CF-SR, 1R1210H-CF-SR, 1R87H-CA-SR, 1R99M-CF-SR, 1R109H-CH-SC, 1R1210H-CH-SR, 1R87H-CF-SR, 1R99M-CH-SR, 1R109H-CH-SR, 1R1211H-CA-SR

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1921-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1921-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-02

Product code KIC

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)