Z-1816-2017 Class II Terminated
FDA device recall Z-1816-2017 was initiated by Hill-Rom, Inc. on February 23, 2017 and is designated Class II. Reason for recall: The bed exit alarm may not function properly if the alarm has been armed for a period longer than seventy-two (72) hours without the alarm being triggered by patient movement or removal of patient wei… The recall status is terminated (terminated September 19, 2017). Affected quantity: 3037.
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2017
- Initiation Date
- February 23, 2017
- Termination Date
- September 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3037
Product Description
TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A).
Reason for Recall
The bed exit alarm may not function properly if the alarm has been armed for a period longer than seventy-two (72) hours without the alarm being triggered by patient movement or removal of patient weight within that time period.
Distribution Pattern
US Nationwide. AUSTRALIA BANGLADESH BRAZIL CANADA CHINA GERMANY INDIA ITALY KUWAIT PAKISTAN SAUDI ARABIA THAILAND UNITED ARAB EMIRATES CYPRUS GREECE NETHERLANDS
Code Information
P1900 SN: K328AM6065 to Q245AM0691 PR1900 SN: L082AL7316 to R343AL4516 U1900 SN: L257AM0541 to O311AM7169 Scale Upgrade Kit P1957A produced after March 13, 2013 (not serialized).