ModerateClass IIOngoing

FDA Devices recall · Reported April 30, 2025

Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on April 30, 2025. Severity: Moderate. Recall number: Z-1666-2025.

Q: Where was the recalled product distributed?

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, WY and the countries of AE, AF, AT, AU, BE, BO, CA, CH, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IS, IT, KY, MY, NL, NO, OM, PL, PT, RO, SA, SE, SG, SI, SL, TH, ZA..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1666-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.

Recall #: Z-1666-2025
Affected scope: 6,961 units
Initiated: April 16, 2025

Compiled from official public sources by the editorial team. · Updated August 2026

Verify with FDA Devices →

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Remote Diagnostic Technologies Ltd. recalled Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headse… - a moderate-severity action.

Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headse… was recalled by Remote Diagnostic Technologies Ltd. in April 30, 2025. Reason: software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscop…. Check the official notice for the remedy. Verify recall #Z-1666-2025 with the FDA Devices before acting.

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The recall

Remote Diagnostic Technologies Ltd. issued this moderate-severity FDA Devices recall-software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscop….

Moderate
severity level: 7K units
affected scope: Class II
classification: April 30, 2025
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1666-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1666-2025) was formally reported on April 30, 2025, with the manufacturer initiating the action on April 16, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Remote Diagnostic Technologies Ltd. is listed as the recalling firm, operating out of Farnborough, N/A. Federal records list the affected scope as 6,961 units.

The documented reason for this recall is: software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope. Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, W…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

6,961 units

Related Recalls

3 from same agency

Product description

Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]

Reason for recall

software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-1666-2025
Date reported	April 30, 2025
Date initiated	April 16, 2025
Recalling firm	Remote Diagnostic Technologies Ltd.
Firm location	Farnborough, N/A
Affected scope	6,961 units
Distribution	Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, WY and th…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

6,961 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1666-2025) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on April 30, 2025. Severity: Moderate. Recall number: Z-1666-2025.

Where was the recalled product distributed? ▼

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, WY and the countries of AE, AF, AT, AU, BE, BO, CA, CH, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IS, IT, KY, MY, NL, NO, OM, PL, PT, RO, SA, SE, SG, SI, SL, TH, ZA..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1666-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 30, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.