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PC600 Digital Thermometer - White

Broder Bros., Co. · Model PC600 · UDI-DI 00030028000041

FLL
10
510(k) clearances
1,321
Adverse events (13 deaths)
19
Recalls
481
Facilities

Description

PC600 Digital Thermometer - White • ABS Plastic thermometer with 1 button cell battery (AG3), replaceable. • Each thermometer comes in 2-piece plastic storage case. Imprint on case only. • Power/Technology: Range 90.0 108.0 F. Accuracy - 0.3 F Less than 95.0 F, 0.2 F 95.0 F to 102.0 F, 0.3 F Greater than 102.0 F. Measures 77.0 F at standard room temperature. • Refer to instructions (included) for cleaning. • Features On/Off switch and 3 1/2 digit LCD display. • For oral and under-arm use only. • Takes approx. 10 seconds to read temperature, at which time device emits beeping sound. Temperature shows on display 30-60 seconds after sound goes off.

Recalls

DateFirmReason
2026-08-20DeRoyal Industries IncMyocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
2025-09-17Baxter Healthcare CorporationAffected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, w
2024-06-13Baxter Healthcare CorporationThe Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
2021-07-20Welch Allyn IncIf the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the us
2019-10-28Cardinal Health 200, LLCThe frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (
2019-10-28Cardinal Health 200, LLCThe frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (
2019-10-28Cardinal Health 200, LLCThe frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (
2019-10-28Cardinal Health 200, LLCThe frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (
2019-10-28Cardinal Health 200, LLCThe frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (
2018-02-02Philips Consumer LifestyleDevice may provide inaccurate measurements.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.