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U.S. Department of Health and Human Services

Class 2 Device Recall Spirit One

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  Class 2 Device Recall Spirit One see related information
Date Initiated by Firm July 02, 2015
Date Posted April 22, 2016
Recall Status1 Terminated 3 on March 24, 2017
Recall Number Z-1555-2016
Recall Event ID 71667
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
Product Spirit One A-C Powered Hospital Bed
Code Information MDL#: E341062; Serial Numbers: B5A00-029643 029644 029537 029538 029539 029412 029413 029092 029093 029430 029431 029432 029433 029411 029479 029480 029463 029658 029461 029462 027773 029536 029420 029421 029423 029424 029094 029095 029096 029097 029098 029458 029459 027772 028853 028854 029563 029564 029639 029640 028835 030097 030099 028845 028846 028847 028848 029416 028003 029177 029418 029427 029428 029558 029559 029560 028834 029419 029429 029416 028840 028842 028843 028844 028836 028837 028838 028839 028849 028850 028851 028852 028841 028957 028958 028959 029460 029466 029467 029468 029415 029648 029460 029466 029645 029649 029650 029652 029654 029655 029657 029659 030096 030098 029467 029468 029656 029417 030154 030157 030158 030159 030161 030223 030225 030226 030354 030100 030152 030439; B5F00-029179 028654 028655 028656 028659 028660 028661 028663 028664 028793 028657 029540 029541 029646 029642 028788 029176 029175 029414 029178 029561 028216 029464 030151; B5C00-029182 029183 029184 029185 029186 029187 029188 029189                  
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
For Additional Information Contact Blaine Burnett
800-327-0770
Manufacturer Reason
for Recall		 Customer complaints associated with faulty brake system
FDA Determined
Cause 2		 Device Design
Action 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).
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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