Spacelabs Patient Monitor Recall for Missing Audible Alarms in End Case Mode
Spacelabs Healthcare is recalling 222 patient monitors because they may fail to provide audible alarms in End Case mode, a defect missed in a previous recall.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a failure of audible alarms in a patient monitoring device, which poses a significant risk of harm to patients if clinicians rely on these alarms for critical alerts, fitting the criteria for a Severe rating.
Plain-English summary
Spacelabs Healthcare Inc is recalling specific models of Spacelabs Medical Patient Monitors (models 91367, 91369, 91370, 91387, and 91393) equipped with Perioperative Mode (option D). The recall involves 222 additional units that were identified during a retrospective analysis of previous recalls and were not included in the earlier recall Z-3032-2011.
The hazard is that the monitors may not provide audible alarms when in END CASE mode, although visual alarms continue to function normally. This issue could lead to clinicians failing to receive expected audible alerts for patient conditions. The affected units were distributed worldwide, including in the United States and various international locations.
Healthcare facilities should identify affected units by checking the serial numbers listed in the official recall notice. Spacelabs Healthcare is providing a software upgrade to correct the issue. The firm will contact facilities to arrange the installation of the upgrade.
The recalled product
- Product
- Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00.
- Manufacturer
- Spacelabs Healthcare Inc
- Category
- Medical Device — Patient Monitor
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1367-000033
- 1369-001517
- 1369-003051
- 1369-003077
- 1369-004247
- 1369-005914
- 1369-006877
- 1369-007165
- 1369-008519
- 1369-010292
- 1369-011637
- 1369-017520
- 1369-061217
- 1370-000013
- 1370-000014
- 1370-000025
- 1370-000095
- 1370-000285
- 1370-000449
- 1370-000471
Distribution
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