Recall record at a glance
| Official record | Z-1997-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Remote Diagnostic Technologies Ltd. |
| Report date | Jul 7, 2021 |
| Recall initiation date | May 25, 2021 |
| Quantity | 510 systems |
| Location | Basingstoke, N/A, United Kingdom |
Official product description
Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).
Why the product was recalled
The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.
Distribution information
Worldwide distribution - US Nationwide distribution in the states of FL, TX, PA, MN, UT, MT, CA, WI, VA, NY, TN, KS, MD and the countries of Australia, Austria, Czech Republic, France, Germany, Hong Kong, Israel, Italy, Netherlands, Thailand, Abu Dhabi, UK.
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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