Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and in suitable rooms in private residences. They may not, however, be used for transportation purposes. Any deviation from this use is expressly excluded from possible liability claims.

FDA Recall Z-2376-2016 · Posted 2016-08-09

Recalling FirmHill-Rom, Inc.
Recall StatusTerminated
Product CodeFNL
Date Initiated2016-06-14
Date Terminated2017-05-15
Product Quantity24262

Reason for Recall

The current construction of the side rail latch may not be able to support the full patient weight and may give way allowing the side rail to abruptly lower and the patient to fall, potentially resulting in harm. To date there has been one report of a related injury.

Firm Action

Hill-Rom sent an URGENT: MEDICAL DEVICE CORRECTION letter dated June 14, 2016 to the affected US and Canadian customers via email and courier, international customers. The letter included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The letter requests the number of beds in the consignees possession so that repair kits can be provided. If you have any questions regarding this safety notice, contact Hill-Rom Technical Support at 1-800-445-3720, your distributor, your Hill-Rom representative or contact us on www.hill-rom.com.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries of: Canada, AUSTRALIA, CHINA, HONG KONG, THAILAND, POLAND, RUSSIAN FEDERATION, SLOVENIA, UNITED ARAB EMIRATES, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, ICELAND, IRELAND, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, SPAIN, SWITZERLAND, and UNITED KINGDOM.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑