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U.S. Department of Health and Human Services

Class 2 Device Recall Liko M220 Mobile Lift

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  Class 2 Device Recall Liko M220 Mobile Lift see related information
Date Initiated by Firm December 23, 2021
Create Date February 16, 2022
Recall Status1 Open3, Classified
Recall Number Z-0639-2022
Recall Event ID 89414
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product Liko Mobile Lifts: Primarily intended for use in nursing homes
Liko M220, Model 2050010
Code Information Serial numbers: 5263715-5269464. Manufactured between 2016-DEC-27 and 2021-SEP-01. UDI: 0887761GMN000034U5
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
1069 State Road 46 E
Batesville IN 47006-7520
For Additional Information Contact Howard Karesh
312-237-6188
Manufacturer Reason
for Recall		 Missing bushing on Liko M220 and M230 causing wear and potential for patient falling
FDA Determined
Cause 2		 Process control
Action HillRom issued Urgent Medical Device Correction Letter (FSCA Identifier: FA 2021-010-002-LUL-001) via third party on 23 December 2021 via UPS Ground Service to Distributors and Direct Users. Letter states reason for recall, health risk and action to take: 1. Review the product label on your Liko M220/M230 to determine if it is impacted by this field action by identifying the manufacturing date of the device (i.e. Manufacturing date between 2016-DEC-27 and 2021 SEP-01). See figure 2. 2. Please periodically inspect your Liko device for damage or wear. Report visible wearing or damage to your Technical Support Team do not use the device until Technical Support can inspect and repair where necessary. 3. Please fill out the attached response form and return it to Hillrom hillromLUL001@sedgwick.com within two weeks Please share this Field Safety Notice with your end users and complete the attached response form and return to hillromLUL001@sedgwick.com within two weeks. Contact hillromLUL001@sedgwick.com to receive an electronic copy of this notification and response form for onward distribution. Action to be taken by the Hillrom: Upon receipt of the response form, identifying potentially impacted devices, Hillrom or an official Hillrom distributor/representative will be in contact to schedule inspection of your device to confirm presence of the bushing. Where it is confirmed the device is missing the bushing, a replacement slingbar with the bushing will be installed. If you have any questions regarding this safety notice, please contact Hillrom Technical Support at 800-445-3720 or technical.support@hillrom.com
Quantity in Commerce 5470 units
Distribution Worldwide distribution - US Nationwide and the countries of Austria, Austria, Bahrain, Canada, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Norway, Saudi Arabia, Sweden, Slovenia, Taiwan (Province of China), South Africa, Oman.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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