FDA Device Recall Z-0016-2007: Sunrise Medical CCG, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0016-2007.

Recall Res Number

Z-0016-2007

Recalling Firm / Manufacturer

Sunrise Medical CCG, Inc.

FEI Number

2182305

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-01-01

Date Posted

2006-10-05

Date Terminated

2007-04-09

Product Code

FNL

Event Number

35816

Product Quantity

6,921

Product Description Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.

Reason for Recall The control box used in the actuator systems appears to have a potential to become stuck in one position resulting a non-functioning bed.

Action Details The objective is to replace all of these systems. Phone contact of affected facilities began in January 2006. All facilities to be contacted by June 23, 2006. All products will be corrected at the location of the end-user by June 30, 2006.

Distribution Pattern Nationwide and Canada.

Code Information / Serial Numbers Model U 770, serial number range: 6149310001 - 6149310005, 6151360001 - 6151360005, 6163290001 - 616330001. Model U770 AL, serial number range: 6099280001 - 6113410042, 6114760001 - 6127920006, 6128720001 - 6130360001, 6130510001 - 6135430002, 6136650001 - 6140860005, 6142190001 - 6142320001, 6142380001 - 6148440006, 6149320001 - 6151270004, 6152090001 - 6160890005, 6161480001 - 6162420010, 6163330001 - 6168440002, 6169170001 - 6171470001, 6171750001 - 6174080020, 6174750001 - 6177310002. U770-GNDAL, serial number range: 6113510001 - 6113510004, 6127970001 - 61279700015, 6130370001 - 6130370003, 6135440001, 6140870001 - 61408700010, 6142330001, 6160900001 - 61609000010, 6168450001 - 6168450004, 6171700001 - 6171720002, 6174710001 - 61747100012.

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Medical Device Recall: Z-0016-2007

Recall Parameters & Description

Related Establishments / Registrations

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