Z-2554-2014Class II

CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL...

Name: Z-2554-2014 CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL...
Creator: Curbell Medical, Inc.
Published: 2014-08-05
License: https://open.fda.gov/license/

Curbell Medical Products, Inc. / initiated 2014-08-05 / Terminated / root cause: design

FDA source

Curbell Medical, Inc. began a recall of CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed... on 2014-08-05. FDA classified it as Class II and gives the reason as "The firm became aware of a potential problem that was initiated by a customer complaint. After consultation with the manufacturer, it was discovered that a resistor was incorrectly placed within the circuit board on the...". 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-2554-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-05
Posted: 2014-08-26
Terminated: 2017-02-28
Recalling firm: Curbell Medical Products, Inc.
Product: CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor --- Monitor is connected to a sensor pad that monitors the patient if they attempt to arise from a bed, chair, floor mat, or toilet seat. The monitor will sound an alarm.
Product code: KMI Monitor, Bed Patient
Reason for recall: The firm became aware of a potential problem that was initiated by a customer complaint. After consultation with the manufacturer, it was discovered that a resistor was incorrectly placed within the circuit board on the monitor. This change to the resistor was a planned change to address a product improvement (improve battery drain). However, this modification rendered the monitor's alarm via the nurse call communication port to not function.
Root cause tag: design
FDA root cause: Component design/selection
Action: Urgent Medical Device Recall Letters (dated 8/01/14) and Response Forms were sent to the consignees via e-mail (w/read receipt) on 8/05/14.
Quantity in commerce: Domestic: 112 units; Foreign: 211 units
Distribution: Nationwide, Canada, Ireland, Italy
Product codes and lots: Lot 0414

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2554-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2554-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26

Product code KMI

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)