Z-1407-2010

Product is a pull cord type monitor, bed patient alarm used to detect patient/resident movement. An...

Name: Z-1407-2010 Product is a pull cord type monitor, bed patient alarm used to detect patient/resident movement. An...
Creator: AliMed Corporation
Published: 2010-02-12
License: https://open.fda.gov/license/

Alimed, LLC / initiated 2010-02-12 / Terminated / root cause: design

FDA source

AliMed Corporation began a recall of Product is a pull cord type monitor, bed patient alarm used to detect patient/resident movement. An adjustable cord is attached to both the alarm and the... on 2010-02-12. The reason FDA records is "Alimed became aware of issue via internal receiving inspection activities on 1/20/09. Firm states that subsequent to this observation, Customer Dissatisfaction inquiry #100192 was generated on 1/22/10. A single unit was...". 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-1407-2010
Status: Terminated
Initiated: 2010-02-12
Posted: 2010-04-16
Terminated: 2011-07-25
Recalling firm: Alimed, LLC
Product: Product is a pull cord type monitor, bed patient alarm used to detect patient/resident movement. An adjustable cord is attached to both the alarm and the patient. When the patient moves beyond the length of the cord the pin is pulled and the alarm activated.
Product code: KMI Monitor, Bed Patient
Reason for recall: Alimed became aware of issue via internal receiving inspection activities on 1/20/09. Firm states that subsequent to this observation, Customer Dissatisfaction inquiry #100192 was generated on 1/22/10. A single unit was received back by AliMed and 0 n/2/1/20 from a rehabilitation center that indicated that it had received a unit and it did not function upon its initial use. Failure of the alarm
Root cause tag: design
FDA root cause: Device Design
Action: Letter sent to customers stating that some units may have been subjected to excessive heat during the manufacturing process causing internal distortion to a key alarm component. The letter also request that the Health Care professional review records and notify all users to whom the product may have been issued and if any product has been issued outside of their facility, to forward this correspondence to them. Firm has enclosed a form for return of the product and issuance of a new product. For questions, please contact the firm using the information provided in the letter.
Quantity in commerce: 30 units
Distribution: All product was distributed domestically with the exception of one unit sold in Canada. AliMed sells and distributes this product to medical health professionals and distributors as well as directly to end users
Product codes and lots: Product Code KMI, Models #710436

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)