Recall record at a glance
| Official record | Z-1816-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Hill-Rom, Inc. |
| Report date | Apr 19, 2017 |
| Recall initiation date | Feb 23, 2017 |
| Quantity | 3037 |
| Location | Batesville, IN, United States |
Official 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).
Why the product was recalled
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 information
US Nationwide. AUSTRALIA BANGLADESH BRAZIL CANADA CHINA GERMANY INDIA ITALY KUWAIT PAKISTAN SAUDI ARABIA THAILAND UNITED ARAB EMIRATES CYPRUS GREECE NETHERLANDS
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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