Spirit One A-C Powered Hospital Bed

FDA device recall Z-1555-2016 · posted 2016-04-22 · Terminated

Recall details

Recalling firm

Stryker Medical Division of Stryker Corporation

Reason for recall

Customer complaints associated with faulty brake system

Action taken

Stryker Corp.sent an Urgent Medical Device Recall letter on July 21, 2015, via FedEx to all affected customers. The letter will identified the product the problem and the action needed to be taken by the customer. Customers are instructed the following actions: 1.Locate the units listed on the attached business reply form. 2.Remove these units from service. (Note: The original mattress purchased with the bed is not within scope of this action. The mattress will be compatible with your replacement option.) 3.Your Stryker Sales Representative will contact your facility to coordinate removal of the recalled beds and present replacement options. 4.Return the enclosed business reply form to your Stryker Sales Representative to confirm receipt of this notification or fax (269)488-8691 or email productfieldaction@stryker.com 5.If you have loaned or sold any of the beds listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. 6.If you have disposed of any of the beds and they are no longer in use, please advise us of their obsolescence by providing us with their serial number in the space provided on the business reply form. *For additional information, please refer to the products operations and/or maintenance manuals. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. If there are any questions or concerns, please contact Stryker Customer Service (1-800-327-0770) during normal business hours are Monday-Friday 8 a.m-6 p.m. (EST).

Root cause

Device Design

Status

Terminated

Product code

FNL

Quantity affected

143 total

Distribution

US Distribution to the states of : AL, AZ, FL, GA, HI, IA, IL, KS, LA, MI, MN, MO, NE, NJ, OH, PA, SC, TN and TX., and Internationally to the countries of : Canada and UK.

Date initiated

2015-07-02

Date posted

2016-04-22

Date terminated

2017-03-24

Location

Portage, MI