FDA recall on some Remstar Pro CPAPs

[miketech]

I don't know if this came up earlier in the year. I have only been reading here for a month or so.

I saw an FDA Recall bulletin :
PRODUCT
Remstar Pro M-Series CPAP and Heated Humidifier System. Catalog Numbers: 1049109, 1049110, 1049111, and AC1049109. Recall # Z-1260-2009

RECALLING FIRM/MANUFACTURER
Respironics, Monroeville, PA, by letter dated February 5, 2009. Firm initiated recall is ongoing.
REASON
Malfunction of the J3 connection between the Heater Plate Main printed circuit assembly (PCA) and the heater plate may have an intermittent connection which may lead to excessive heat build-up on the humidifier PCA.
VOLUME OF PRODUCT IN COMMERCE
449,585 units
DISTRIBUTION
OR, OH, KY, TX, MO, AZ, IN and NV and countries of United Arab Emirates, Bosnia, Belgium, Bulgaria, Bahrain, Canada, Czech Republic, Denmark, Egypt, Spain, Finland, Greece, Croatia, Hungary, Ireland, Israel, Jordan, Kuwait, Lebanon, Latvia, Macedonia, Netherlands, Norway, Oman, Poland, Portugal, Romania, Qatar, Russia, Slovenia, Turkey, Serbia and South Africa

I think the catalog number listed above might be the model number you find on the bottom of the machine.
What this recall notice is saying is that some of these units with humidifiers were found to get overheated inside (on the printed circuit board). Respironics was supposed to send letters to all owners of these that they knew about in the states and countries listed. I don't know if they were going to make a repair to the effected machines or replace them.

[TheDreamer]

Guess I'm safe....I'm in KS. And, the humidifier and my Pro were separate items.... Humidifier is 1051158, don't recall what the machine number was...pretty sure it was the unspecial 400M. Going by browser autocompletion choices on the Respironics registration page. The important thing I guess is that I registered my equipment on the Respironics website, so they know what I have.

The Dreamer.

[GumbyCT]

The important thing I guess is that I registered my equipment on the Respironics website, so they know what I have.

I thought of doing the same thing but if Respironics won't even talk to you (unless you are a DME), what good is it?

Let's hope you don't need it.

I saw an FDA Recall bulletin :
PRODUCT
Remstar Pro M-Series CPAP and Heated Humidifier System. Catalog Numbers: 1049109, 1049110, 1049111, and AC1049109. Recall # Z-1260-2009

Where did you see this recall announcement?

[Wulfman]

The important thing I guess is that I registered my equipment on the Respironics website, so they know what I have.

I thought of doing the same thing but if Respironics won't even talk to you (unless you are a DME), what good is it?

Let's hope you don't need it.

I saw an FDA Recall bulletin :
PRODUCT
Remstar Pro M-Series CPAP and Heated Humidifier System. Catalog Numbers: 1049109, 1049110, 1049111, and AC1049109. Recall # Z-1260-2009

Where did you see this recall announcement?

I did some searching in the FDA site and found some links (you may have to do a page search on "REMstar" or "Respironics").

http://www.fda.gov/Safety/Recalls/default.htm

http://www.fda.gov/Safety/Recalls/Enfor ... 120504.htm

http://www.fda.gov/Safety/Recalls/Enfor ... 120437.htm


Den

[fuzzy96]

http://www.accessdata.fda.gov/scripts/c ... m?ID=81028


goes right to all respironic recalls

[GumbyCT]

Thanks...
All mine begin w/102
fwiw - Looks like the 104's are DC powered.

[TheDreamer]

http://www.accessdata.fda.gov/scripts/c ... m?ID=81028


goes right to all respironic recalls

Hmm, the OP is misleading...it says "Respironics was supposed to send letters to all owners of these that they knew about in the states and countries listed."

But, the recall above says "A Service Communication dated February 5, 2009 was provided to all Respironics customers that are approved to service Respironics devices."

That's a big difference.

The Dreamer.

[TheDreamer]

Thanks...
All mine begin w/102
fwiw - Looks like the 104's are DC powered.

So, older ones aren't DC powered? I guess that explains the difference in some of the discussions on whether its safe to use integrated humidifier on a backup powersource. Since mine (105) is DC powered....

The Dreamer.

[fuzzy96]

A Service Communication dated February 5, 2009 was provided to all Respironics customers that are approved to service Respironics devices


sounds like only the dme's know about this, key being the woeds-"customers that are approved to service "

[GumbyCT]

But, the recall above says "A Service Communication dated February 5, 2009 was provided to all Respironics customers that are approved to service Respironics devices."

Not ALL registered users?

[Wulfman]

http://www.accessdata.fda.gov/scripts/c ... m?ID=81028


goes right to all respironic recalls

Hmm, the OP is misleading...it says "Respironics was supposed to send letters to all owners of these that they knew about in the states and countries listed."

But, the recall above says "A Service Communication dated February 5, 2009 was provided to all Respironics customers that are approved to service Respironics devices."

That's a big difference.

The Dreamer.

Yep.....BIG difference! The "Respironics customers" are the DMEs. The corporate offices wouldn't KNOW who the "owners" are. The communication about the recall would have to come from the sellers/resellers/DMEs, etc......TO the owners.


Den

[fuzzy96]

The communication about the recall would have to come from the sellers/resellers/DMEs, etc......TO the owners.

how many times will that happen???? who will know they have a bad machine????? appearantly this is due to the class of the recall ie 1,2,or3
not a good setup for end users

kinda like ford telling thier dealers to call ya about your wheel that might fall off. then we can blame the messenger if it don't get through

[OwlCreekObserver]

Yep.....BIG difference! The "Respironics customers" are the DMEs. The corporate offices wouldn't KNOW who the "owners" are. The communication about the recall would have to come from the sellers/resellers/DMEs, etc......TO the owners.

Den

Back when I worked for a DME (non-respiratory stuff) we used to receive recall notices from manufacturers every now and then. It was usually a listing of serial numbers that were affected and we had to track down which serial numbered items went to which of our customers. It's been a long time, but it seems to me that we had to respond to the manufacturer with a count of how many units we could locate and then they'd send us the replacement parts to install. It was a bit of a hassle, but one of those things that any responsible company would do.

My CPAP DME, on the other hand, can't even be bothered to return phone calls for routine supplies. I would not be at all surprised to learn that they also blow off recall notices. I'm in the process of changing sleep doctors and will dump these guys shortly.

OCO

[miketech]

Sorry, folks. I didn't mean to mislead. In all my excitement, I guess I stopped reading at " to all customers....".

I got the bulletin from another "forum" I read daily (before I sought sleep treatment). I belong to a forum dedicated to Biomedical Equipment Technicians. One of the regulars posts the weekly bulletins that the FDA publishes. It is also possible to subscribe to the FDA mailings, but if you look at it, you will find that it has quite a lot of notices about foods, drugs, and unusual devices.

It would be interesting to find out if any of the cpaptalk readers have gotten notified by their DMEs to bring their machine in? Certainly there must be someone who has one of those machines....

Mike

[diboraha]

Does anyone know any websites that talks about the hidden agenda of the FDA? Im doing a school project and need info on the FDA(Food and Drug Administration). How they allow harmful things in the food, and how meat is bad! Things along that line.