FDA recall on some Remstar Pro CPAPs

Canada has recalled model 1051158.

Recall Posting Date 17/08/2009
Trade Name M Series Remstar Heated Humidifier System
Manufacturer Respironics Inc.
Recall Start Date 31/07/2009
Recall Number 50202
Hazard Classification Type II
Model or Catalog # 1049109, 1049110, 1049124, 1051157, 1051158, R1049109, R1049110, U1049109, U1049110
Lot or Serial # N/A
Reason for Recall Some humidifiers may fail to operate due to a potential malfunction of the internal connection between the heater plate and the circuit board which results in a blinking blue light on the control knob.

Okay, mine is the 1051158.......what do we do if ours is listed? Phooey. I just got the thing in June. Don't think my DME would help me. (Seeing as how he has not let me know it's a recall.....)

Tough chit for your DME provider. He is REQUIRED to handle the Recall. Put the squeeze to him. Contact Respironics, tell Respironics the date of the sale of this recalled humidifier to you by your provider and also tell them your provider has not notified you of the recall and ask how you should handle having your recalled humidifer replaced. Either your provider will straighten up and fly right and handle the recall or Respironics will handle the recall thru an independent but will have your provider on their "list".

It wasn't tech a recall. It was basically advise the client and if they have problems with the machine, respironics would replace it. It was a voluntary recall. The exact wording is "Some humidifiers mail fail to operate due to a potential malfunction of the internal connection between the heater plate and the printed circuit board which results in a Blinking blue light on the humidifier control knob." "This action does not require replacement of normally operating humidifiers." Humidifiers affected are humidifiers shipped from April 2008 through December 2008 and within the serial number range of H001579050 through H002850376. Respironics is only replacing humidifiers which have the blinking blue light and are within the serial numbers listed.

Again I say it was a voluntary recall, only for those machines within the serial number range listed in the above post and on only those machines having a problem. If your humidifier doesn't have the blinking blue light it is unaffected by the voluntary recall. All DME's are required to notify end users of any recall...If they did not then report them....

The M Series integrated humidifier was very poorly designed (to put it mildly) and has been thru 2-4 "fixes". It was such a headache for Respironics notice the design of the new PR SystemOne integrated humidifier. I think the blinking blue light was developed for the FOURTH fix.

rjjayrt wrote:It wasn't tech a recall. It was basically advise the client and if they have problems with the machine, respironics would replace it. It was a voluntary recall. The exact wording is "Some humidifiers mail fail to operate due to a potential malfunction of the internal connection between the heater plate and the printed circuit board which results in a Blinking blue light on the humidifier control knob." "This action does not require replacement of normally operating humidifiers." Humidifiers affected are humidifiers shipped from April 2008 through December 2008 and within the serial number range of H001579050 through H002850376. Respironics is only replacing humidifiers which have the blinking blue light and are within the serial numbers listed.

Since I bought my machine through CPAP.COM and not a DME how do I handle the issue? I have the blinking blue light on the humidifier knob, my serial number is within those listed, (002320469) but I bought mine from CPAP.COM in March of 2008. Who do I deal with?

Jeff

jrfoster wrote:Since I bought my machine through CPAP.COM and not a DME how do I handle the issue? I have the blinking blue light on the humidifier knob, my serial number is within those listed, (002320469) but I bought mine from CPAP.COM in March of 2008. Who do I deal with?

Jeff

I'd contact CPAP.com, if I were you. I'll bet they take care of it. They are your "DME", after all, as far as Respironics is concerned.

AND, cpap.com takes pretty darn good care of their customers!

Slinky wrote:AND, cpap.com takes pretty darn good care of their customers!

I know that they do. I just emailed them and will most likely hear from them tomorrow. Can't get that darned blue light to stop blinking!

Jeff

Is there a place where I can get a comprehensive list of biomedical products pending FDA approval? I'm looking for investment ideas, and I feel like this would be a helpful tool. Just something that shows such-and-such product was put in for FDA approval on this date.

kabina wrote:Is there a place where I can get a comprehensive list of biomedical products pending FDA approval? I'm looking for investment ideas, and I feel like this would be a helpful tool. Just something that shows such-and-such product was put in for FDA approval on this date.

Google?

FDA website?

kabina wrote:Is there a place where I can get a comprehensive list of biomedical products pending FDA approval?

In general, the FDA considers this kind of information both proprietary and confidential. They generally neither publicize it nor comment on it.

I have a Remstar Pro M 1051158... the blue light is not flashing, but the machine mysteriously comes on for no reason when I'm reading at night. I don't know if it is also going off in my sleep, but I don't really want to take a chance! Has anyone else had this problem?