FDA (Devices) recall action 97176
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired. The labels placed on the projectors do not meet requirements specified in 21 CFR 1010.4 (Variances), 21 CFR 1010.2 (Certification), 21 CFR 1010.3 (Identification) and 21 CFR 1040.10 (g)(Labelling requirements). The identification label does not include the date of manufacture as required by 21 CFR 1010.3. The corrective action plan covers three families of laser light show of projectors: DIODE. CLUB and PURE with three d…
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
BLS laser light show projectors, models CLUB 1000, 2000 and 4000, are being recalled because the remote interlock connector required by federal regulation was not installed or was not wired. 12 units affected.
BLS laser light show projectors, models PURE 5000 and PURE 10000, are being recalled because the remote interlock connector required by federal regulation was not installed or was not wired. 3 units affected.
BLS laser light show projectors, models DIODE 1000, 2000 and 3000, are being recalled because the remote interlock connector required by federal regulation was not installed or was not wired. 10 units affected.